LWPES Members: Medtronic is voluntarily recalling all Quick-set® infusion sets for MiniMed Paradigm® insulin pumps whose lot number begins with 8 (“Lot 8”; model reference numbers MMT-396, MMT-397, MMT-398 and MMT-399). Patients are instructed to discontinue using Lot 8 Quick-set infusion sets immediately, and Medtronic has implemented a replacement program at no charge. Approximately 2% of the Lot 8 Quick-set infusion sets (estimated 60,000 sets currently with customers) were discovered to have venting issues. In these 2%, a lubricant has clogged the vents incorporated into the tubing connector, thereby interfering with the pressure equilibration between the pumps’ reservoir compartment and the ambient atmosphere. As a result, rapid increases in altitude (such as airplane takeoff and driving up a mountain) can lead to over-delivery of insulin and severe hypoglycemia; this over-delivery may not be detected until after it has occurred. Conversely, even at stable altitudes, interruption of insulin delivery and hyperglycemia can occur due to increased reservoir air pressure from the priming process. The lubricant has been eliminated from the manufacturing process, such that other lots of the Quick-set infusion sets are safe to use. Patients who may have affected products are being notified by Medtronic, but physicians should be aware as well. Aberrations in frequent glucose monitoring values should raise suspicion about faulty infusion set function, which should be replaced immediately even if some insulin is discarded in the process. Patients are asked to notify Medtronic by the routes listed below if they have (and even if they don’t have) any unused Lot 8 Quick-set® infusion sets. Patients will then be provided pre-paid UPS labels with which to return the Lot 8 Quick-set® infusion sets to Medtronic and further, receive at no cost replacement infusion sets that will be shipped at a rate of one box every three weeks until all their Lot 8 sets have been replaced. Important contacts: |