Events

Recall of ACCUCHEK Connect Diabetes Management App

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diabetes Care, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70775
  • Event Risk Class
    Class 2
  • Event Number
    Z-1369-2015
  • Event Initiated Date
    2014-10-30
  • Event Date Posted
    2015-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134687
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • 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.

Device

ACCUCHEK Connect Diabetes Management App
  • Model / Serial
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    ACCU-CHEK Connect Diabetes Management App; Instruction Manual || Designed to transfer data for diabetes management.
  • Manufacturer
    Roche Diabetes Care, Inc.

Manufacturer

Roche Diabetes Care, Inc.
  • Manufacturer Address
    Roche Diabetes Care, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA