BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1369-2015 · Initiated October 30, 2014

    Recall

    Recall Number
    Z-1369-2015
    Event Number
    70775
    Firm
    Roche Diabetes Care, Inc.
    FEI Number
    3011393376
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 30, 2014
    Posted
    April 2, 2015
    Terminated
    June 8, 2015
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    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

    Action

    Urgent Field Safety Notices were sent to the customer and healthcare professional starting on 10/30/2014. The letter provided a description of the reason for the notification; and recommended that all users should update their app immediately.

    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.