United StatesThe InPen App (Model/CFN MMT-8061) for Android users, software versions 7.5.0, 7.5.1, and 8.0.0 (UDI-DI 00763000974596), sold in the United States and many international markets, is affected. When the app is uninstalled and reinstalled the Choose Notification Style screen may not display and previously granted override permission can be deleted so audible and vibratory notifications are not received, which may lead to delayed insulin therapy and hyperglycemia.
What's being recalled
InPen App, Model/CFN Number: MMT-8061 (Android Users)
Recalling firm: Medtronic MiniMed, Inc., Northridge, CA, United States.
How to identify it
Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596
The hazard
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI, MD, PA, OK, KY, MA, DE, UT, ID, VA, MI, OH, LA, NJ, IA, MT, HI, AR, OR, SC, AL, CO, WY, VT, NV, GA, MS, SD, AK, WV, NH, ND, NM. OUS: Austria, Belgium, Chile, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, United Kingdom
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)