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.

17 Responses to:

“Medtronic Insulin Pump Lawsuit: Recall of Quick-Set Infusions Sets for MiniMed Paradigm Insulin Pumps”

  1. JAMES Says:

    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.

  2. Kourtney Says:

    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.

  3. Toni Says:

    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!

  4. Dan Says:

    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.

  5. John Says:

    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.

  6. Timothy Says:

    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!!

  7. Tricia Says:

    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.

  8. Susan Says:

    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.

  9. Vicky Says:

    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!

  10. Linda Says:

    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.

  11. michael Says:

    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.

  12. Jackie Says:

    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.

  13. Alex Says:

    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.

  14. Macy Says:

    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.

  15. Michelle Says:

    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 8) 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!

  16. michael Says:

    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.

  17. Stacey Says:

    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?

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