Medtronic Insulin Pump Lawsuit: Recall of Quick-Set Infusions Sets for MiniMed Paradigm Insulin Pumps
Following the recall of Medtronic infusion pump Quick-set infusion sets issued Friday, the product liability lawyers at Saiontz & Kirk, P.A. are reviewing the potential for lawsuits on behalf of individuals who have suffered severe or fatal injuries as a result of the pumps delivering to much or too little insulin.
>>FDA LINK (7/13/2009): Medtronic Paradigm Quick-Set Infusion Set Recall
Late in the day Friday, Medtronic announced that approximately 60,000 Quick-set infusion sets used with the Medtronic MiniMed Paradigm insulin pumps could be defective and not work properly. Therefore, they recalled an estimated 3 million of the infusion sets with reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with an “8”.
The thin plastic tubes are used with the MiniMed Paradigm Medtronic insulin pump to deliver insulin to diabetes patients. The infusion set is typically replaced every three days. However, thousands of patients may have been sold infusion sets that may not allow the insulin pump to vent air pressure properly, potentially resulting in the device delivering too much or too little insulin.
Over or under delivery of insulin from an insulin pump could have serious and catastrophic consequences for diabetes patients.
MEDTRONIC INSULIN PUMP LAWYERS
Individuals have been told to stop using “Lot 8” Quick-set infusion sets and Medtronic is offering to exchange all affected products at no charge. However, for individuals who have been hospitalized or suffered severe injuries as a result of incorrect delivery of insulin from their pump, the recalled units should be saved until after it is determined whether financial compensation may be available through a Medtronic insulin pump lawsuit.
If you, a friend or family member experienced Medtronic insulin pump problems after using any of the recalled Quick-set infusion sets, request a free consultation and claim evaluation.
I WAS HOSPITALIZED IN JANUARY DUE TO KETOASIDTOSIS JUST ABOUT 1 WEEK AGO I RECEIVED AN E-MAIL ABOUT THE RECALLS OF PUMP SUPPLIES. I HAVE MANY MEDICAL BILLSFROM ICU AND THE WHOLE TIME I WAS IN THE HOPSPITAL. MY BLOOD SUGAR WAS EXTREMLY HIGH MY WIFE CALLED 911 WHEN I WAS UNCONSCIESE. I MISSED SEVERAL DAYS OF WORK AND MY FAMILY THOUGH I WAS GOING TO DIE. I WAS NOT STABLE FOR SEVERAL DAYS.
I was recently hospitalized twice in the same month, both for complications from my diabetes. The first time was on the day of prom and my eighteenth birthday and I was told I had ketoacidosis so I was transferred to a larger hospital. The second time was a couple weeks ago. This time I had checked my sugar all day after feeling sick, and it stayed in the five-hundreds all day long. I would take the reccommended dose of insulin through my pump, but my blood sugar continued to rise. When it was up in the six hundreds I went to the hospital and told the doctors that I did not think my pump was working. I was transferred once again to another hospital about an hour or two away and they did nothing for me. I came in with a broken pump and left with a broken pump. I am glad to know what was actually wrong with it and I have experienced quite a few problems since and have not felt the same in a few months. I reviewed my infusion set box to discover that the lot number and reference numbers mach those above. I am a very young girl and I hate having to be hospitalized so much. I am missing out on everything and I know that one day these high blood sugars will take a toll on my body. My doctor told me that my age is on my side as of now but the damage will be present later on and it is something I can not take back. I hope there is sonething that can be done, as I am also paying for these infusion sets since my insurance does not cover the cost.
While I did not experience anything extreme using the 8 series -however quite often after changing the set and primping my pump I would get very high blood sugars for about 8 to 10 hours (in 400s). Then finally it would get back to normal. I don’t know if the air pressure will got normal after a using it a while or not. I have been on a pump since 1983 and has been wonderful!
My girlfriend was admitted for DKA, dehydration and projectile vomiting a couple of months ago. A couple of weeks ago I woke up in the middle of the night to find her dying from low blood sugars as a result of Medtronics’s defective Quick Set Infusion.
I woke up on fathers day sick as a dog. My blood sugars were over 500.I was disoriented, vomiting and barely conscious.My domestic pardner came home from church, found me and called 911.I was taken to the hospital and was in intensive care for 2days. I was release from the hospital on the fourth day.I was treated for ketoasiditosis.I did not understand at the time what cause my sugars to be so high.I had followed my normal regimentation and had changed my infusion set the day prior to episode.I did not realize that there was a problem with pump until I was release from the hospital.Approximatly 10 days later I get notification from medtronic that a recall for the supplies that I was using.
I was wondering why my sugar was over 500 many times because it had never happen before. I had to keep hitting the manual bolus button to lower my sugar. I have not returned my defective sets. One day it hit 600, and I almost had to go to the hospital. However after repeted bolus I lowered it to 200. Then I received the I am sorry note from Medtronics asking me to return the defective product that could have killed me!!
Andrew had a major grand mal seizure due to too much insulin delivered by the lot 8 sight. WE had to take him to the hospital for help where the doctor did not believe his seizure was caused by low blood sugar. He had never seen this kind of seizure before. I was astounded!! They treated him with IV and cereal and released him. I am mad! Andrew never got the note from Mini Med till the following week! I want them to pay for his medical expenses.
Husband hospitalized for ups and downs, I am a wreck. 18 months of this and I finally wound up on Lexapro, he lost his job, had a wreck, I could not make sense of it since all had been great for 2 yrs….then suddenly big ugly push by supplier to send back infusion sets followed by letter from MM to they had defect. Didn’t someone know? I even called MM and asked if something could be wrong with the pump last year. Scary and very very stressful.
When my sugars wouldn’t get lower than 600 I started worrying about, “what did I eat, did I forget to bolus, is the injection site on scar tissue…what is going on?” I freaked and began injecting insulin “the old fashion way” finally after 3 hours and phone calls to the doctor, the sugars began to come down, but I did sit outside the ER in the event that after the 15th injection didn’t work, I’d go in. I am never that high and started second guessing my management. However, I did feel relieved when I received the recall notice and that it wasn’t my fault!
Like so many others who have commented on the site, I have been plagued with extreme blood sugar highs and lows with no apparent reason. Because I do not like waking up and looking into the faces of 911 personnel, and now having the fear of never waking up, I now wear a subcutaneous sensor to monitor my sugar 7×24. It vibrates or produces an audible alarm to alert my husband when my sugars go out of control. So far, with the “new” Quick-Sets, I have not had any unexplained raises or falls in my sugar levels.
I have been on the pump for the last 2 years, I have had some issue’s like others. I had to go to the hospital after a very bad sugar low because my heart got a good work out from the low, those of you who have had these in the middle of the night and awake is this condition know what your heart goes through. If it had not been for my wife being there and taking care of me I do not know if I would still be here, I was unable to even get out of the bed. I called Med-Tronic and asked that I did not think it unfare to have the 24 box’s of LOT #8 I have recived in the last 2 years be replaced at no cost to me. I got their reply today. They think they are not responsible. Again I did have to go to the hospital the next day thinking I had a heart attack. I spent 2 days in the hospital under observation. And belive me that is not cheap. Now note I did not ask to be reimbursed for that cost just for the supplies that I had paid for that had put my life at risk per their letter that was sent with a new box of Quick-Sets. Am I the only one or did they not make this sound like the most important thing to ensure that you did not die in this letter.My wife has kept everything we have ever recived from Med-Tronic all the meters the box pump came in all the quicksets box’s, every E-Mail or letter sent. I don’t know why but I am sure glad she did. I do not care about their money I don’t need it, what I need is someone I can count on to be there for me with help with my health where the diabetes is conserned. We all know what the low’s and high’s make us go through, what about our loved ones who worry and have to put up with the BAD MOOD’s that we go through with it we have no control over it because we are sick. And do not understand be cause our mind’s are not working right, we become confusied, mad, crying, and sorry afterwards for our temper and the thing’s we have said or done when our mind’s we not right. Do we not have enough trouble with out HELP of this nature. We all need to speak to our local News and radio people to get the word out DO NOT TRUST these people $$$$$ is their game and not your well being. Also there is a state regularty commission for you state call them make a complaint call yor congress man anyone who has any clout that can help address this matter need’s to know and be held responciable for their help we pay their bill’s at home for them and they work for us. STAND UP and be counted.
I have my 2nd MM pump, the Paradigm. However, I use the Silhouette Infusion set. I too have experienced unexplained extreme blood sugars. I am wondering if anyone out there has experienced the following problems with their pump sites: after 3 days, change the site but the old site (w/ band aid and antibiotic cream) have developed into a boil. This has not been fun! I would appreciate feedback. Thanks.
I have had two insulin related attacks to my body in about 20 years. Since I started received bad infusion sites in January I have had about 8, of which I had to use glucagon shots to shoot my bloodsugar up and not having a fatal attack. The strain put on my family has been enormous, not knowing if I should be left home alone or not. One time, with just me and a friend at the house I started shaking and not making any sense not being able to talk. The paramedics were called and from the time this was happening til they got there I had been drinking juice provided for me by my friend since I was not capable to do this myself. Many headaches, seizures, and severe moments of confusion later, a recall notice and a set of new infusion sites wound up at my door when I was being given a glucagon shot. I do not find this acceptable for I have had injuries preventing me from school and every day activities. No serious injuries recorded but the frequent refills of glucagon shots and many injuries to the head and body.
My sugar was over 500 many times because it had never happen before. I had to keep using the manual bolus button to lower my sugar.
one weekend I was so high they call the ER my Ketones were so high the Dr said to my parents to give me shots every two hours. Because I was so high my mom took me to the Dr the next day and she inform us about the recall.
My Mom call metronomic they toll her to send the Quick set # 8 she send one box back and then they send us a UPS box with the notification from medtronic that they were recalling lot 8 we send two more boxes back but the supply is so slow the my parents think that the shots are better I am only 14 but I feel bad for my parents because the are drowning in my own medical bills for experience highs to long .
But medtronic does not care about us only about the money they make.
I have experienced similar situations. My blood sugar levels started rising to the 500′s and 600′s and I was not able to bring them down. I was so frustrated because this has never happened to me before. I’ve been on the pump for 9 years under good control, but during the past 6 months I have not been able to keep my levels under control. One time I woke up with cramps and vomiting and almost had to go to the hospital. I have called Minimed numerous times and all they say after running a test over the phone is that I need to change my quickset because it’s clogged. Finally in July I got the letter from Minimed explaining the defective “Lot 8″ . I was glad to know it wasn’t my fault ! I have been so sad and frustrated that I am now having to take Lexapro. I have spent so much $ on Dr’s visits, ordering supplies earlier because of having to switch my Quickset so often. I have no idea how much damage this could have caused and it’s not fair! I have been diabetic for 32 years and this is the first time my A1c’s are over 8. I like to do sports and play USTA leage tennis and I can’t even do that anymore. I’m also missing work because I feel so sick everytime this happens. Minimed just replaced my last order (only what I had left from the Lot
and did not want to replace the Quicksets I had already used that almost killed me. I started using the new supplies I got and apparently they are also deffective. My pump keeps saying “No delivery”. I have changed my set 3 times between yesterday and today. On top of everything I have to pay $600 to Minimed because my insurance isn’t covering the supplies. They placed my account on hold because by the time I had to order supplies my balance was not paid off. I had to beg them to release the hold, but why should we be going through all this when they are the ones at fault. We are talking about our health and our future. I want to be able to see my grandchildren and that is why I have taken care of my diabetes for such a long time!
Michelle I came back to this site to see if anyone else was having problems with the lot 2 new infusion sets. I also am having trouble with them not giving the correct amount on insulin the same trouble that I was having with lot 8. Some time’s to little most the time to much and am having sugar low’s. I would like to take a shot of insulin and give a very large dose to who ever run’s this outfit and overdose them and see how they like what happens to them. This is getting to be a little to much to put up with. I am thinking about just going back to the shots, at first the pump was like a dream come true, I was taking 7 shot a day and not in controll, but the pump has brought me close to being in controll and it is nice to only have to every three day’s pop the infusion set on. But is it worth you LIFE, that is the question. And Med-Tronic does not seem to care about that. And is it not funny that no matter what you go to the Dr. for it is always blamed on DIABETES. And you are told you need to see your Endocrinology Dr. Beleave me I know the things it can cause. But not every problem we have is from our DIABETES. Thanks for letting me vent. My GOD bless all of you who are having trouble and this issue be resolved soon that we again begin to live as close to normal a life as we can. HOPE JOY and FAITH in JESUS be with all of you.
The lot 8 infusions caused me to have a seizure. My blood sugar reading was 15 when I got to the hospital. Doctors and nurses could not believe I was still alive. 3 days later the Fed Ex driver was knocking on my door with a package from Mini Med about the recall !! Does anyone know if there is a class action lawsuit for this yet?
I have been on the pump over 6 years now and never had any problems. My control was always great. Only recently I have run into major problems. During the day twice my bloodsugar was over 600 for no apparent reason. It took a long time to get the sugar down again. Then one morning my bloodsugsr was 500 something that has never happened in the past. I got replacement sets for the lot 8 sets and am currently using lot ..7256. I am seriously considering going bakc to shots!!!
I have only been type one diabetic for 3 years and was put on the pump 6 months after being diagnosed..in these few short years I have, many times, thought about switching back to shots. Even though the pump is more convinent, I was so much heathier when I was taking 10-15 shots daily. My A1C was remarkably lower as was my day to day blood sugars. I did not recieve the information about this recall until the entire box was gone! I am very dissapointed in the company. Though I never went to the hospital (because I am too stubborn) looking back at the month in which i used these ‘bad injection sites’ there were several times in which I should have. There were days which my blood sugar reached from 500-600. Hopefully something gets done about this issue!! An 18 year old should not have to go through this, noone should. We should be able to trust our supplier..however with every injection site I question their Quality.
My brother kevin Died November 8, 2008 . After Kevin’s death they did a recall. To late for my brother but I hope to help save someone life. It is my familys goal to let the world know bout this. If you have any questions please go to our website. http://www.mothersagainstmedtronic.com/ We will have all the info that you will need and if you dont find what you are looking for we have a contact page. We are hope the set up chapters all over the U.S. Please if you would like to be a part of this let us know.
We were alerted exactly one year to the day AFTER our son died of the problem with the pump. Before his death he was having extreme high’s and lows that his Doctors and employers dismissed as him not taking his disease seriously. We know now it wasn’t his fault but it’s still to late for him.
sounds like a lot of people are having problems with mm. although my wife does not use the same sets as the recall she constantly has problems with extreme blood sugars. the other morning after leaving for work her blood suger dropped dramatically. her driving became erratic and someone called 911 on her because they thought she was drunk.somehow she managed to pull over before she wrecked,although there was a scratch on the truck were she obviously hit something. if her blood sugar was fine when she left the house how could she be low to the point of affecting her driving within ten minutes.i dont know what kind of sets she used last but had problems with them, she called the wonderfull people at minimed and they basically told her to switch sets. also they did send her new sets for free. which leads me to believe that they are having problems with all ther sets. sorry about the rambling but just spent the last three hours feeding the wife mountin dew to get her sugar up
My brother Billy passed away this January, 2010, in the last year he must have gone to the hospital 6 times, because his sugar was sky high, or it was so low he almost went into a coma,
The last time I saw him, he told me he was having trouble with his insulin, that it would get out of control, and he was having the hardest time getting it back down to normal, and controlling it was crazy. He said it would get so high, it was so hard to get it under control, that it scared him, It scared me to hear my brother say he was scared, I asked if he was ok, he said now I am, but it scared him when it got so high, it would just take so long to get it back under control, he said I do everything right, I don;t know what I am doing wrong. It just gets so out of control, My sister found him a couple of days later, in his bathroom., He had been diabitic around 25 years, He knew something was wrong,
2nd letter, My daughters husband’s sister just got her recall notice in June 22, 2010, They have known of this problem since 2008. This is so wrong.
i was hospitalized three times in 2009 in DKA, each time I spent several days in ICU. I had been on the insulin pump for two years prior with no problems. I have been diabetic since I was 10 and have never been in the hospital. I now am 46. Medtronics was contacted the first episode and they sent me a new pump. It did not solve my problem. I ended up back in the hospital 2 more times. I do not feel that 2 consultations with a salesman in the doctors office is enough education to be given when it depends on your life.
Why all you folks with sky high sugar readings didn’t take insulin with a syringe is beyond me. Give yourself a shot and get to the Doctor, it’s really not that difficult. Use the settings in your pump and your glucose reading to figure out the dose.
3 year pump user and love it.
I’m not looking to sue anyone!!
Thanks for sharing Steve.
I have been on the pump and Continuous Glucose Monitor for 3 months. Nothing but trouble with all of it. I have had Quicksets fail to work. Pumping dose after dose to who knows where. Steve, after you have given yourself many units, why would you resort to shots? That’s a great way to crash with way too much insulin.
Last weekend my Quickset caused an onset of intense kidney pain. I thought I was having a Kidney Stone attack. I was heading for teh ER when I puiled the Quickset out and the pain instantly started fading.
My CGM constantly discinnects. I have called Medtronic about it and they said radios and cellphones interfere with the device. Duh! They did not properly test this device before handing them out. Who doesn’t ahve a cellphone?
It has lots of great features, but, it has some serious issues.
My mother was a diabetic for 17 years taking 8 shots a day and in august of 2010 she went to the medtronic pump and was doing okay for awhile then in october the doctor put her on a stronger insulin, i think it was u-500. She wasn’t monitored on the insulin and wasn’t trained properly for the pump. She started getting migraines, disoriented, fatigue and losing her ability to walk. Sick for two weeks, doctor finally admitted her into the hospital then her blood sugar dropped to a 34 then it went up to 366 and almost to 400 and wouldn’t go back down. She was still having migraines and vomiting. Had mri’s and mra’s, sonograms and other tests. She was told that the pump may have a defect in it to where it was shooting too much insulin and was too strong for her body. She was getting insulin when she didn’t need it and it was going to her brain. She was told that half of her brain was dead. She was also told that every migraine she was having, was a stroke. Three days later, she had another stroke and went into a coma. She passed away on november 15, 2010.
I repeatedly had low blood sugars with no relationship to what I was eating or what had previous been working (basil and bolus) with my pump or to any change whatsoever in diet or lifestyle or exercise. Several times I was seriously disoriented and confused–causing harm at work and making driving unsafe. Other times I would have very high blood sugars, again with no reason. I did “fix” the high sugars with injections of insulin. But, I complained to my doctor and Metronic rep to no avail about what seemed to be spurts of insulin and slowing down of delivery. Life became a constant testing. Then the company did the recall. Finally.
I do not want to sue anyone; but I do expect safe materials.
I am having a problem with inserting the infusion set and then noticing a few hours later my sugar going up to around 300 or 400, I then know something is wrong with the pump and decide to take a shot and change the infusion set out. When I pull it out of my stomach the tube is actually bent. Which is why I think I am not getting insulin. Anyone else had this problem?
Tiffany, I’ve had a similar problem with the Quick Set infusion sets and not using the insertion device, which I was told was not needed.
I had many very high sugars, above 500, the candula would bend. My dr. finally took me off the pump.This was very exp. with all the med bills and now that the problem is supposed to have been fixed, they only will allow me $500 on a new pump. Hell no, and I guess I will stay on the needle 4 times or more a day. Thank you for letting me vent.
I was in the hosp. in 2005 with DKA. My sugar lived in the 300-400′s. Initialli in the hosp. I left the pump on me, and my #”s were still awful. the doctor had me to detatch and began shots. My #’s came down and I was home in about a week. Started pumping again and my #’s were crazy until about 2010. My sugar is still high at times but not as bad. Just wondering if the effects I still have today is related to the pump? Could I still hace a claim? Wondering about the statute of limitations in OH since this was 2005?
I stay mentally “foggy,” no stamina and my husband has to help with the house. Luckily, I’m in a career that I can sit at my desk and still do my work, though those around me are not aware of just how bad I am feeling.
I am 42 and have been on the medtronic paradigm for 2 weeks, and I have felt terrible. I and my rep (who is great, by the way) have changed by basal/bolus rates often, but we are now thinking that it’s my absorption that is the problem. After 30 years of giving shots (mainly in my stomach) I have much scarring. I don’t like not knowing if the place I am putting my canula is a place with scar tissue or not – how am I to know? My sugars last night went above 500 and this is horrible to me! I feel like having been on the pump for two weeks, may have caused me tissue damage that I was able to avoid during 30 years of insulin shots. Maybe I should to back to shots? The worst part is the severe lows, and having days when my blood sugar would go from one extreme to another. I am very frustrated with my pump and don’t know what I should do. I apologize that I am just kind of rambling right now.
I had the same problem with the tubing in 2010. My high blood sugars developed suddenly .It took about 2day for me to be right. I had to take several syringe injections. Now the insertion site cannula issue this is my 2nd time with this problem just recently 08/07/11. After several syringe injections having to go to work feeling lousy,tired no energy hard time focusing I had to leave workearly I came home change the site and found the cannula bent. the first time this happened it never inserted under my skin. What the heck is going on? Medtronic should be more responsible to their users.They provide a life sustaining service which I know i depend on.I now know I have to pay closer-much closer attention to my symptoms even though i have been a pump user for over 13 years.
My son Kevin died November 8. 2008 This was before the recall. I did everything in my power to let the FDA know something was wrong. Medtronic didnt even care. I hate them.They have causrd our family terrible pain. My son was in the prime of his life. Kevin onhly had the pump for about a year and a half. I didn’t want him to get one but he was old enough to make his own choices. When he died his blod sugar was 1164. Yes , he lived alone went into a coma and died.Stay away from anything made by medtronic
My nephew passed away on August 22, 2009! He had the medtronic insulin pump for one year, and was in the ICU five times during that time. He was only 14 years old at the time. His sugar was over 1200. Medtronics needs to pay!
My son has been using the Medtronic for 5 years. He has experienced many lows which caused ER visits. He would seize and dislocate one or both of his shoulders. He had surgery on one and is planning surgery for the other. I cannot say that his lows were caused by the Medtronic, however, weeks prior to the recall, he suffered 1-2 seizures a week. I am upset that I (or my son) did not investigate the situation further. I came to this site when I was checking on the J&J pump recall. You feel helpless in this situation because diabetics are dependant on these and other medical supplies. I won’t even go into how the drug companies’ main revenue is from diabetic supplies. Will there ever be a cure when the companies prosper so much from the disease?
On 11/2/11 I was hospitalized for high blood sugars and dehydration for the fist time in 20 years. I was on the phone with MiniMed for 45 min yesterday asking for help and not once did they say anything about this problem and I am using lot 2. This is very scary and stressful.
My son has had this happen several times and it seems to be the quick sets. Sometimes when I prime them it won’t go through and if you take the needle out of the reservoir and reinsert it then it works. Usually a large dose of insuline squirts out then. Sometimes it just won’t prime and then all of a sudden primes on it’s own. I think this happens and sometimes no alerts go off or he’s sleeping and doesn’t hear or feel the alert and then he’s getting no insulin and ends up with high sugars. Other times I believe it doesn’t come out then a large dose spurts out all at once and it causes lows. I don’t believe they’ve fixed the issues regarding these quick sets at all. I even called about this in July of 2010 and they sent new sets but haven’t fixed the issue in my opinion because it is still happening and his numbers have been quite erradic this past 8 months or so. His A1c was always good and that’s been higher also. Will be keeping any sets he removes if he gets any alerts and not sending them in to medtronic in case I need them for a lawsuit in the future. Thank god we have been able to fix his highs and lows without hospitalization but these swings in blood sugar are bad for his entire body. Thinking about putting him back on the shots though I know he will be very disappointed as he loves having the pump.