BEUDAMED
    FDA Enforcement Class II Terminated

    Insulia Diabetes Management Companion

    Recall: Z-0478-2019 · Reported November 28, 2018

    Enforcement

    Recall Number
    Z-0478-2019
    Event ID
    81508
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Voluntis
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    November 28, 2018
    Initiation Date
    October 8, 2018
    Classification Date
    November 16, 2018
    Termination Date
    March 12, 2019
    Address
    22 Quai Gallieni, N/A, Suresnes, N/A, N/A, France

    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.

    Code Info

    Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40

    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