BEUDAMED
    FDA Enforcement Class II Terminated

    ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.

    Recall: Z-1369-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1369-2015
    Event ID
    70775
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    October 30, 2014
    Classification Date
    April 2, 2015
    Termination Date
    June 8, 2015
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.

    Reason

    Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough investigation of the situation revealed that this issue may occur if the user changes the screen orientation of the phone from portrait to landscape or vise versa while looking at the Bolus Advisor or Carb

    Code Info

    N/A

    Distribution

    There are no US distributors as the affected device is not marketed in the US. The affected device was distributed in Germany, Italy and South Africa. The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.

    Quantity

    The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.