BEUDAMED
    FDA Enforcement Class II Terminated

    Accu-Chek Connect Diabetes Management App

    Recall: Z-1099-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1099-2017
    Event ID
    76147
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    February 1, 2017
    Initiation Date
    December 20, 2016
    Classification Date
    January 26, 2017
    Termination Date
    September 5, 2017
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Accu-Chek Connect Diabetes Management App

    Reason

    iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple meters with the Accu-Chek Connect app can under rare circumstances cause the bolus advisor to fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement (10  15 minutes). Depending on the individual metabolic situation potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Both software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect and should not be used to manually calculate a bolus.

    Code Info

    Catalog number 07562462001 / GTIN number 00365702700000 Catalog number 07250452001 / GTIN number 00365702700017

    Distribution

    Worldwide Distribution - Nationwide Distribution The Accu-Chek Connect App for iOS is distributed directly to end users via the Apple App Store. The Accu-Chek Connect App for Android is distributed directly to end users via the Google Play App Store.

    Quantity

    27243