Device 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.
Z-0741-2023
Product summary
- Event
- Event 91158
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 140
- Official record key
device-enforcement:Z-0741-2023
Official wording
Reason: 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.
Code information: InPen Software App for Android, versions 5.6.1.1 and 5.6.2 with InPen System REF/UDI-DI: MMT-105ELBLNA/10862088000313, MMT-105ELGYNA/10862088000320, MMT-105ELPKNA/10862088000337, MMT-105NNBLNA/10862088000344, MMT-105NNGYNA/10862088000351, MMT-105NNPKNA/10862088000368.
Distribution pattern: US Nationwide distribution including in the states of CA, NY, MT, OH, IN, MN, PA, CT, TX, WA, TN, SD, MI, FL, OR, NC, KY, WI, MO, WV, NV, SC, AZ, AR, MA, LA, VT, GA.
Derived failure modes
-
Unknown
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.