InPen Diabetes App crashes, preventing dose reminders
The InPen Diabetes Management App may crash on certain Android versions, preventing dose reminders and potentially delaying insulin therapy. This could affect users of the diabetes management system.
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 3/5 (High).
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: Class II medical device recall for a system failure that could prevent delivery of a critical medication reminder, potentially delaying insulin therapy. No illnesses or injuries have been reported to date.
Plain-English summary
Companion Medical is recalling versions 5.6.1.1 and 5.6.2 of the InPen Diabetes Management App for Android due to a crash issue. When the app crashes immediately upon opening, while in use, or while running in the background, it may fail to display dose reminders to users.
The failure to display dose reminders could lead to delayed insulin therapy and potentially result in elevated blood sugar levels (hyperglycemia). This affects users who depend on the app for diabetes management and insulin administration.
Approximately 140 units have been distributed nationwide, including in California, New York, Montana, Ohio, Indiana, Minnesota, Pennsylvania, Connecticut, Texas, Washington, Tennessee, South Dakota, Michigan, Florida, Oregon, North Carolina, Kentucky, Wisconsin, Missouri, West Virginia, Nevada, South Carolina, Arizona, Arkansas, Massachusetts, Louisiana, Vermont, and Georgia.
The recalled product
- Product
- InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.
- Manufacturer
- Companion Medical, Inc.
- Affected units
- 140
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)
- InPen Software App for Android
- MMT-105ELGYNA/10862088000320
- MMT-105ELPKNA/10862088000337
- MMT-105NNBLNA/10862088000344
- MMT-105NNGYNA/10862088000351
- MMT-105NNPKNA/10862088000368.
Distribution
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