United StatesThe MiniMed Go mobile app (MMT-8600 for iOS, MMT-8601 for Android), software versions 1.0.0 and 1.1.0, is recalled; 3,465 units were distributed worldwide including the United States and listed countries. In these versions, if “Set day and night” is turned OFF while missed-dose or Correct high glucose alerts are enabled, the associated alerts may not trigger at night, which could result in missed rapid-acting insulin doses and increase the risk of hyperglycemia.
What's being recalled
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Recalling firm: Medtronic MiniMed, Inc., Northridge, CA, United States.
How to identify it
Model/UDI-DI: MMT-8600/00199150038978(10)1.1.0, MMT-8601/00199150038985(10)1.1.0 Software Versions: 1.0.0, 1.1.0
The hazard
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of 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
Worldwide - US Nationwide distribution in the states and territories of PR, OH, WA, IL, NC, PA, VA, MN, ID, CA, UT, MI, NJ, MS, SC, CO, AZ, OR, AR, MO, TX, AL, FL, NY, IN, TN, IA, WI, MA, LA, OK, GA, KS, NM, CT, KY, NH, NV, MD and the countries of Australia, Switzerland, Germany, Denmark, Spain, Finland, Iceland, Norway, Sweden.
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)