BEUDAMED
    FDA Recall Terminated

    Insulia Diabetes Management Companion

    Recall: Z-0478-2019 · Initiated October 8, 2018

    Recall

    Recall Number
    Z-0478-2019
    Event Number
    81508
    Firm
    Voluntis 22 Quai Gallieni Suresnes France
    FEI Number
    3013530341
    Product Code
    NDC
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    October 8, 2018
    Terminated
    March 12, 2019

    Description

    Insulia Diabetes Management Companion

    Reason

    The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is now available (version 1.6.42), which resolves this issue.

    Action

    On October 15, 2018, patients were notified that they could download the new version of the application from the Google Play Store. The notification was made through an automated message displayed on the application screen of all impacted patients requesting them to update their Insulia application. Patients were informed that the new version of the app resolved a an issue with the basal calculator identified on the Android version of the application. Patients who do not upgrade to the new version by November 9, 2018 will be blocked from using the app until they upgrade. For technical assistance or if you have any questions, please contact the Insulia support hotline.

    Distribution

    Distributed to accounts in Arizona, Masachusetts, Michigan, Ohio, Tennessee, and Vermont. International distribution to Canada and France (however, French customers are not affected by this recall).

    Quantity

    14