Infusion sets connect an insulin pump to the body of a person with type-2 diabetes. Medtronic has become aware of reports of potential over-delivery of insulin shortly after an infusion set change.
The problem is that a vent membrane in some of the sets could be blocked by fluid. These blockages may occur during the process of pump priming (or removal of air bubbles) and fill-tubing.
A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly.”
If the vent membrane is blocked, it could potentially result in over-infusion of insulin. Over-delivery of insulin can cause extremely low blood-sugar levels (hypoglycemia) and death in extreme cases.
Medtronic has received reports of hypoglycemia that may be linked to the blocked vent membrane. Some patients required medical intervention. In response, Medtronic has discontinued the affected vent membranes in the infusion sets.
Francine Kaufman, chief medical officer of Medtronic’s diabetes group, recommended that customers use only infusion sets made with the new and enhanced membrane.
Infusion sets manufactured after April 2017 include a design update that Medtronic believes reduces the risk of insulin over-delivery after an infusion set change.
Customers in the U.S. can determine if they have recalled infusion sets by visiting https://checklots.medtronicdiabetes.com.
You will be prompted to enter the REF and LOT numbers for all infusion sets in your possession. The website will then tell you which infusion sets are part of this recall and which are not. If you have additional questions, please call Medtronic at 1-888-204-7616.