Insulin pen app recalled over notifications lost after reinstalling the app
Medtronic MiniMed is recalling 8,251 units of the InPen App for Android because reinstalling the app deletes the notification override permission, so audible and vibratory alerts are not received.
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: Scored 3 under the risk-of-harm criterion: the firm states missed notifications may lead to delayed insulin therapy and hyperglycemia, and no injuries are reported.
Plain-English summary
The InPen App, model MMT-8061 for Android users, software versions 7.5.0, 7.5.1 and 8.0.0, from Medtronic MiniMed, Inc., is being recalled. The product carries UDI-DI 00763000974596.
When the app is uninstalled and reinstalled, an insulin pen software issue causes the Choose Notification Style screen not to show during setup, so users cannot choose to allow notifications to override phone settings when the phone is on mute or Do Not Disturb, and the previously set up override permission is deleted. As a result audible and vibratory notifications are not received, which the firm states may lead to delayed insulin therapy and hyperglycemia.
The record lists 8,251 units, distributed across Illinois, Arizona, Minnesota, Nebraska, Kansas, Tennessee, California, Florida, Texas, Washington, Missouri, North Carolina, New York, Wisconsin, Indiana, Maine, Connecticut, Rhode Island, Maryland, Pennsylvania, Oklahoma, Kentucky, Massachusetts, Delaware, Utah, Idaho and Virginia. The FDA has classified the action as Class II.
Users should follow Medtronic's instructions and check their notification settings after reinstalling the app.
The recalled product
- Product
- InPen App, Model/CFN Number: MMT-8061 (Android Users)
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Diabetes app
- Affected units
- 8,251
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 (3)
- Software Versions: 7.5.0
- 7.5.1
- and 8.0.0. UDI-DI: 00763000974596
Distribution
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