Medtronic has issued a recall of specific lots of infusion sets that are for use with MiniMed Paradigm insulin pumps. These infusion sets may not work properly, resulting in a delivery of too little or too much insulin, which could result in injury or death.
The infusion set is the thin plastic tube that delivers insulin from the pump to the diabetes patient. They are typically replaced every three days by the patient. Four different styles of infusion sets are affected, with reference numbers MMT-396, -397, -398, and -399. All affected infusion kits (about 60,000) have lot numbers beginning with the number 8, and are referred to in the recall as “Lot 8” Quick-Set infusion sets.
To find out whether your Quick-Set infusion sets are affected by this recall, look for the lot number on the product label or on the individual infusion set packaging. The lot number is a seven-digit number (8XXXXXX) located on the left-hand side of the packaging next to the boxed word “Lot” and under the reference number. According to Medtronic, about 2 percent of the sets are defective, representing about 60,000 out of the total lot of 3 million infusion sets.
If you have experienced any adverse effects as a result of these or other Medtronic insulin pump products, they invite reports at any time at 1-800-345-8139.
Audrey Brannon says
No one bother to tell me or write me about this. My Doctor, nor Medtronic.
I heard when I finally called to order a refill. I had been having problems with elevated CBG’s (400+) per Insulin not dispensing well from infusion tube for a few weeks.
William Lutz says
I was notified one day by getting a UPS box with a case of infusions. Sorry to hear that Audrey.
They told me there were so many being recalled, that I’d have to get mine periodically, instead of all at once
Medtronic did have a problem with the Lot 8 infusion sets, but were very quick to handle it IMHO…they could have been like a good many other companies with a wait and see attitude, but they recalled the sets also telling you exactly why they were recalled, and replaced them with a working set sending 1 box (10 count) out to their patients until they were all caught up.
I had problems, but I was also sick so elevated Bg is expected.
I’m sorry that some had gotten the problems, but also grateful that Medtronic acted swiftly else we could have been worse off
I have a client who’s wife died. The recall came after her death. She was 46.