InPen App Software Error May Miss Insulin Dose Reminders
Medtronic is recalling certain InPen App versions due to software errors that could cause missed insulin dose reminders. The app may fail to alert users, potentially delaying diabetes treatment, though no actual incidents have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or adverse event reports. The defect is a risk-of-harm product (failed insulin reminders could lead to hyperglycemia), but per the rubric, recalls with theoretical harm and no reported injury score at most 3.
Plain-English summary
Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors in certain versions. The affected versions are MMT-8060 (iOS: 7.0.0, 7.1.0, 7.2.0, 7.5.0) and MMT-8061 (Android: 7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0, 7.5.0). The software errors could cause the app to fail to send short-acting insulin dose reminders and fail to recommend correcting high glucose values.
Approximately 6,816 devices have been distributed internationally to 34 countries. The defect does not impact insulin delivery itself, long-acting insulin dose reminders, or continuous glucose monitor alerts. Users can continue to use the InPen device manually to calculate doses, deliver insulin, record dose information, and view CGM data.
The software error was identified during internal testing before the app's U.S. release but after the app had been distributed to international customers. No user complaints or adverse event reports have been reported related to this recall to date.
The recalled product
- Product
- InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
- Manufacturer
- Medtronic MiniMed, Inc.
- Hazard
- missed-insulin-reminder
- hyperglycemia
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 (6)
- UDI-DI: 0763000B000122075 CFN/Software Version: MMT-8060/7.0.0
- 7.1.0
- 7.2.0 and 7.5.0 MMT-8061/7.0.0
- 7.0.1
- 7.1.1
- 7.2.0 and 7.5.0
Distribution
Distribution scope not specified by the agency.
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