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.
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.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0741-2023