This evening I arrived home to find a UPS package from Medtronic Minimed. It contained information about a recall of all Quick-Set Infusion Sets with Lot numbers beginning with an 8 with the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399. The package also contained a fresh box of replacements with instructions to stop using the Lot 8 sets and ship them back to Medtronic.
Medtronic estimates that 2% of Lot 8 (approx. 60,000 out of 3 million) are faulty and may cause over-delivery or under-delivery of insulin while the pump appears to be working properly. These errors are caused by faulty vents and can occur whether in a stable altitude or stable air pressure, or during a change in altitude or air pressure.
If you use Quick-Set Infusion Sets and haven't yet received a package with replacements and instructions, Medtronic's instructions are to use one of the following:
- Silhouette infusion sets
- Sof-set QR / Sof-set Ultimate QR infusion sets
- Sure-T infusion sets
- Polyfin infusion sets
- Revert to the back-up injection plan established with your doctor
Medtronic anticipates all customers will receive the same package I received by this Friday, July 10. For more information, click here to visit this special web page regarding this product recall.
Post a Comment