Medtronic have issued a recall to insulin pump users on specific lot numbers of MiniMed infusion sets, following reports of potential over-delivery of insulin, shortly after infusion set change.
The over-delivery of insulin can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process.
This most likely happens if insulin, alcohol or water is spilled on top of the insulin reservoir, which could stop the infusion set working properly.
This could lead to hypos, and there have been reports of severe hypos, requiring medical assistance that could potentially be related to this issue.
To resolve the issue, infusion sets currently being shipped by Medtronic contain a new membrane material that significantly reduces the risk of insulin over-delivery.
Medtronic has issued the following actions for users of its insulin pumps:
1. Go to the Medtronic website to find out if you have the recalled infusion sets. You will be prompted to enter the Ref and Lot number for all infusion set boxes in your possession. The website will then tell you which infusion sets are part of this recall and which are not.
2. Medtronic recommends you do not use recalled infusion sets.
If you have new and enhanced infusion sets that are not part of this recall, use only those new and improved sets starting with your next set change.
If you only have recalled infusion sets, it is very important to carefully follow the instructions for use regarding the priming/fill-tubing process. You will find key steps enclosed.
3. Discard recalled infusion sets when you have new and improved infusion sets and follow instructions on the website.
Medtronic will replace the recalled infusion sets free of charge.
Emma Elvin, Diabetes UK Clinical Advisor, said: “It’s important that anyone using Medtronic MiniMed pump infusion sets checks the Medtronic website to see if they are affected by this recall. If people have concerns about unexplained hypos or their level of insulin they should consult with their diabetes team.”
For more information, visit the Medtronic website or call Medtronic on 01923 205167. Or talk to your diabetes team for advice.