BEUDAMED
    FDA Recall Open, Classified

    InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.

    Recall: Z-0741-2023 · Initiated November 8, 2022

    Recall

    Recall Number
    Z-0741-2023
    Event Number
    91158
    Firm
    Companion Medical, Inc.
    FEI Number
    3012822846
    Product Code
    NDC
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    November 8, 2022
    Posted
    December 20, 2022
    Address
    12230 World Trade Dr, Ste 100, San Diego, CA, 92128-3796

    Description

    InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.

    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.

    Action

    On 11/8/22, Medtronic emailed correction notices to customers who were asked to do the following: 1) Verify the running app by: a) Open the app on the device, b) From Home screen tap the "Settings" button, c) Select the "Help and Support" option, d) Under Contact Us section, note the app version listed. 2) If affected app versions are not listed, no action is necessary. 3) If affected apps are listed, uninstall the app and reinstall the version currently available in the app store (5.5.4.4) by following these steps: a) Perform an app search for InPen, b) Tap the icon to the left of the Open button, c) Tap the Uninstall button, d) Confirm the uninstall, e) Tap the Install button. 4) After reinstall and log into the InPen app all past data will remain available and visible within the app logbook. 5) Acknowledge receipt and understanding of the correction notice. The firm provided the following 24-hour technical support phone number: 1-800-646-4633, option 1.

    Distribution

    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.

    Quantity

    140