Events

Recall of Device Recall 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
    76147
  • Event Risk Class
    Class 2
  • Event Number
    Z-1099-2017
  • Event Initiated Date
    2016-12-20
  • Event Date Posted
    2017-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152299
  • 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, drug dose - Product Code NDC
  • 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.
  • Action
    Customers were notified via Google Play Store or the Apple App Store that an update to the Accu-Chek Connect App was available on December 20, 2016.. The description of the new version available in the app stores indicated that the new version resolved issues with the Bolus Advisor. It also includes direction to the Accu-Chek website. On December 21, 2016, information regarding the issues corrected with the new version was placed on the website. The information on the website was replaced on January 10, 2017, with the patient version of the Urgent Medical Device Correction (UMDC) which was sent on January 10, 2017, to US HCPs who have received prescription pads that would allow them to prescribe the bolus advice activation. If you have additional concerns, please contact the Accu-Chek Customer Service Center at 1- 800-858-8072. All other versions of the app as well as other Accu-Chek products using the bolus advice feature are not affected by this issue.

Device

Device Recall AccuChek Connect Diabetes Management App
  • Model / Serial
    Catalog number 07562462001 / GTIN number 00365702700000 Catalog number 07250452001 / GTIN number 00365702700017
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Accu-Chek Connect Diabetes Management App
  • 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