Medtronic Paradigm Recall: Quick-Set Infusion Sets for MiniMed Insulin Pump

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Medtronic Inc. has recalled three million disposable infusion sets designed for their MiniMed Paradigm insulin pumps after discovering that some of them could deliver incorrect doses of insulin, potentially leading to injury or death.

The Medtronic Paradigm recall involves one lot of Quick-set infusion sets, which are disposable plastic tubes used to infuse a diabetes patient from the Medtronic insulin pump. They are usually replaced after three days. Medtronic issued a press release on July 10 alerting users that approximately 2%, or about 60,000 units, from one lot of its infusion sets have a defect that could give too much insulin to the patient.

The affected infusion sets have a lot number starting with “8” marked on the product box label and on each infusion set package, with the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399. The defective infusion sets do not vent air pressure properly when delivering an insulin dose.

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The sets were distributed throughout the United States and to a small number of countries outside of the U.S., such as Germany, Mexico, Brazil, Great Britain, Canada and the Bahamas. There have been no reported injuries related to the insulin pump infusion set recall, but the defect has the potential to cause fatal injury.

Last month, the FDA issued a warning letter to Medtronic about Synchromed and MiniMed pump problems. The agency warned the company that it needed to fix quality control issues in its Puerto Rico plant where the products are manufactured. According to FDA investigators, the plant had a wide range of problems that included lax testing of products for defects, proper record keeping, and employing someone with only a high school education and some special training as a medical expert for determining the danger of defects.

Medtronic is offering patients replacement Quick-set infusion sets for the MiniMed Paradigm insulin pumps in exchange for the defective ones at no charge. However, product liability lawyers who are investigating potential lawsuits for Medtronic insulin pump problems caused by the recalled Quick-set infusion sets, indicate that any units from the recalled lots should be preserved for litigation purposes if a serious or fatal injury has occurred.

Tags: Diabetes, Insulin, Insulin Pump, Medtronic, Medtronic Paradigm, Medtronic Recall, MiniMed Pump
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71 Comments

Victoria
I had fallen and hit my head numerous times from low blood sugars. A couple of times, I was knocked completely out since I was on concrete when I fell. Since I live alone and my family didn’t want me to stay in my home, I finally gave in and went to the ER on March 13th of this year. I fell in the hospital bathroom, broke my glasses and had to have 7 stitches put over my eye. My BS was under 10. After having every test imaginable, the doctors told me to stop wearing the pump and get a new one. I have and have had no other problems. Had my father not seen the article in the paper, I would have never known. The left over infusion sets that I had from my Medtronic pump were the lot starting with an 8. I was so relieved to know it wasn’t me and something I was/wasn’t doing to take care of myself. I was on the verge of having to sell my house and move in with family. It would have been nice if Medtronics would have contacted us. That’s adding insult to injury!
Jacy
My father just spent a week in the hospital due to insulin shock resulting in brain damage all thanks to a plastic tube.
ali
SOme of your stories are very sad, I am sorry. I was curious though since the methosd is to take your pump off after 3 lows or 3 high sugar readings, why has this not been figured out sooner. my daughter as been on this pump and has lot 8’s (many) but bnothing came of it. I just know that in the past, we were always able to determine if it were the pump causing the issue with the sugar due to not using the pump and going back on shots. The blood sugar ceases to be normal in a few hours or a half a day, somewhat. This si weird. I know trhere were planty of occasions that we took her off the pump becasue her blood sugar was funky. THere have been a handful of bad sites, not just the product but the resivour twisting inside , and so on.
Karen
Crap and of course I mailed mine back instantly because they said they would not send me more until I did so. I am soooo angry
Brenda
My daughter has been using the minimed for a year and a half with great results. I still have great faith in Medtronics. My father also has one of their products. He has a defribulator and just last week it SAVED his life.
cheryl
I have the lot number 8.. we went to oklahoma and my sugar dropped so fast and hard that the last thing I remember after all the glucagon and honey and mints I ate was that I twisted the pump off of my stomic and it hit the floor. I had several more episodes and put it in the drawer. I went back to the pens. When I got the letter I called the company and told them I wanted the money back I paid for the pump. I am afraid to use it now. They said no way and to send them the bad sets. I am hanging on to them in case there is a lawsuit. I am still paying for the pump and cant use it now.
Betty
Why am I just finding out about this?? I called to order new supplies from Edgepark and was told there would be a little bit of a delay since the problem with the infusion sets. That was the first I heard about it. Thank you Edgepark. I’ve been having trouble regulating my blood sugars for a while now. I have one box left with the mentioned coding, so I don’t know if the other two boxes were from this lot or not. I feel really let down by Medtronic. Why didn’t I hear about this from Medtronic? I’ve been very depressed and hopeless in trying to regulate my blood sugars. My two doctors have been mystified by my lack of interest in getting my blood sugars regulated.
Jennifer
I let my blood sugar run high these days since I am so terrified of another 29 or 23 and unconsciousness again. I live alone. While I am happy to find out I am NOT a bad diabetic and it was the fault of this product, I can’t help but wonder how many months of my life are gone a a result of this Lot 8????? I have been higher than ever before and lower than ever before. All because of lacking quality control in Puerto Rico where teenagers are given the responsibilty of creating the product that gives or takes my life from me. Who thought it was okay to lay that kind of responsibility on some kids?
Trina
My mom passed away January 3rd 2009. I was told it was natural causes, she had only been on the pump for 4 weeks. I questioned the pump but was told it wasn’t the problem. I got a letter in the mail yesterday about the recall, she too was using lot 8.
Donna
My sister has had numerous problems with the insulin pump. She had numerous spells.. couldn’t figure out what was happening. Discovered she had all lot 8…. Yes,,, we need to start a class action suit!!!!!
Lauren
I got on a plane with one of these sets last week and it resulted in mass overdelivery of insulin and four hours of severe low blood sugars. It only stopped when I injected emergency Glucagon to reverse it. The very next morning I discovered that I was running high 500 to 600+ blood sugar levels until lunch time. This had lovely consequences as well, including LOTS of vomiting and illness (ketones!). Why did Minimed not CALL patients about this? I could have died on this trip! Thanks, Minimed! Is there a class action lawsuit for this or what?
Lynn
My son had the same problem about 10 months ago. He was in the hospital with ketoacidosis. They almost put him in ICU, but thankfully he responded to the IV just in time. We knew it was the infusion set at that time. Minimed knew, too, and called me several times about it. I can’t believe it took them this long to do a recall. It’s scary to think of how many others had to suffer.
Julie
I, too, have been seriously harmed through the use of those infusion sites. I was so far into ketoacidosis that my legs were mottled, my kidneys had failed and when I came out of the coma I was temporarily blinded. I spent nearly 5 weeks in the hospital-most of the time in ICU. Even with health insurance I incurred serious debt-not to mention the trauma I put my young daughter and family through. Medtronic needs to take responsibility for their product!!!
barbara
My husband (type 1) has been using the pump since 2001. Recently he has not been able to control his sugars (too high). Complained to doctor, changed site, basal rate, but nothing worked. April 30th, blood vessels in his right eye burst causing hemmoraging which was due to high sugars. He had laser surgery in his left eye in May. He allso used lot 8 and since using replacement set has his sugar levels under control.
Neriah
They are FDA approved. I was not hospitalized but if there becomes a lawsuit out of it then count me in. I trust my health to this company and they dont even have good quality control on their product? Its meant to make life better and save lifes, not destroy them and cause death.
Wendy
My son died on 5/19/09, age 21. He was using this product.
Ginger
My grandaughter 17 years old, diagnosed with Type I at nine months. She just suffered a Grand Mal Seizure, and had used a box of the series 8 supplies. Biting down during this seizure, she dislodged a lower tooth and cracked her mandible. The pain is severe and the seizure was life threatening. She depends on her insulin and pump for her life everyday and minute. Her disease is not new for her or the entire family, and this was caused by the infusion set and not through her own actions. She recieved a letter for the recall on July 7th and it was too late.
Pat
My daughter was also placed in the hospital for DKA for high blood sugars and in late 2008 was in the hospital for 5 weeks for low blood sugar. The doctors said she was trying to kill herself by giving herself to much insulin or not enough. The doctor went as far as having her Baker Acted. She has suffered a lot of emotional stress. And She still has not been notified of the recall, I found it online by chance. We also need a lawyer!
Peggy
My son just got out of ICU on Saturday. He spent 4 days in ICU. He was admitted for DKA and dehydration stemming from this sets. We just received the letter via UPS about the recall and the new sets. Since he changed his site and started using the new quick sets his blood sugars are back to normal, but, he continues to have severe headaches. Our daughter is diabetic also and was having the same symptoms and was using the same quick sets that started with “8”!! Anyone else having any problems?
jeff
My daugfhter was put in ICU a month ago ($20,000 in hospital bills). She was suffering from ketonacidosis. It is clear it was casued by her infusion set; she used lot number 8. Since switching sets, she is doing fine. We need a lawyer. I haven’t seen reports of other victims–are you out there?
bart
are these infusion sets fda approved
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