Companion Medical Inc
FDA adverse event reports naming Companion Medical Inc as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: COMPANION MEDICAL INC.
- Total reports
- 9,108
- Deaths
- 3
- Injuries
- 423
- Malfunctions
- 8,682
Reports per year
Source: FDA adverse event reports by year received, 2020–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
Recent recalls
- 2022-12-20Open, ClassifiedSoftware design
InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.
Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating the app has stopped or isn't responding. After the crash, a present dose reminder is not displayed, which may lead to delayed insulin therapy and potentially resulting in hyperglycemia.
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