Medtronic MiniMed Go App Recall for Insulin Dose Reminder Failure
Medtronic is recalling the MiniMed Go app version 1.2.1 because a software defect prevents long-acting insulin dose reminders from appearing, potentially leading to missed or duplicate doses.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a software defect that may lead to hyperglycemia or hypoglycemia due to missed or duplicate insulin doses. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medtronic MiniMed, Inc. is recalling the MiniMed Go app for iOS and Android, software version 1.2.1. The recall involves a software defect that causes the long-acting dose reminder feature to fail for users who had previously enabled this feature in version 1.2.0 or earlier. The issue is caused by a type cast exception during database migration that occurs when updating to version 1.2.1, resulting in a silent failure that prevents the creation of new alerts.
The long-acting dose reminder is an optional feature that triggers a notification to remind users to take their long-acting insulin dose. The failure of this reminder may result in missed or delayed insulin doses, potentially leading to hyperglycemia. Conversely, if users are uncertain whether they took their dose due to the missing reminder, they may inadvertently duplicate the dose, potentially resulting in hypoglycemia.
The affected units were distributed nationwide in the United States in the states of AL, CA, CT, FL, LA, MA, MD, NY, OH, PA, and TX, as well as in Austria, Belgium, Denmark, Finland, Germany, Iceland, Italy, Norway, Spain, Sweden, Switzerland, and the United Kingdom. The source text does not specify the number of affected units or report any illnesses, injuries, or deaths.
The recalled product
- Product
- Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1 Product Description: The MiniMed Go app for iOS or MiniMed Go app for Android is compatible with the following…
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Software
- Affected units
- 623
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Code: GTIN for MMT-8600
- iOS: 00199150038978 GTIN for MMT-8601
- Android: 00199150038985 UDI for MMT-8600
- iOS: 00199150038978 UDI for MMT-8601
- Android: 00199150038985 Software version 1.2.1
Distribution
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