FDA-Device2022-12-28Class II
InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.
Companion Medical, Inc.
Hazard
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.
Sold states
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.
Affected count
140
Manufactured in
12230 World Trade Dr Ste 100, San Diego, CA, United States
Products
InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0741-2023Don't want to check this manually?
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