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
    77635
  • Event Risk Class
    Class 2
  • Event Number
    Z-0197-2018
  • Event Initiated Date
    2017-06-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156980
  • 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
    Certain ios and android app versions contain a program error (bug) in the bolus advisor feature. after pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. this same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed).
  • Action
    Roche Diabetes Care sent an Urgent Medical Device Correction letter dated June 12, 2017, to all affected customers. The potential for inaccurate bolus insulin advice can only be encountered if the blood glucose meter has displayed a single E-10 Time/Date error message and the meter had blood glucose records in My Diary and then the meter is pared for the first time with the Accu-Chek Connect App. A customer encountering this issue may find the app does not display the bolus advice option and, consequently, correction bolus advice is not available on the most recent, valid glucose reading. This blood glucose value that could not be used initially may become available for bolus advice calculation at a later time. If the app provides the bolus advice option more than 15 minutes after you tested, it could lead to an incorrect bolus insulin recommendation that should not be used. To completely avoid the possibility of this issue occurring, it is important for Accu-Chek Connect app users to follow the following directions when pairing a meter with the app for the first time: Clear all data from your Accu-Chek blood glucose meter following the steps below, before pairing with the Accu-Chek Connect app for the first time. This clearing of the records in the memory can be accomplished on your PC or Mac by using Accu-Chek Connect Device Link. A micro-USB cable and an Accu-Chek Connect Online account are required. Also ensure that the date and time are set correctly on your blood glucose meter before pairing with the app. Failure to follow these directions might impact first time use of the apps Bolus Advisor feature. Steps to clear data from your Accu-Chek meter in Connect Online: 1. Create or login to your Connect Online account on your PC or Mac. 2. Download Accu-Chek Device Link 3. Right-click on Device Link icon in system tray or dock. 4. Select Settings >Prompt after every successful upload under the Delete Patient Results from Device heading. 5. Connect y

Device

Device Recall AccuChek Connect Diabetes Management App
  • Model / Serial
    Software Versions 1.0.5, 1.0.15, 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, 2.1.0, and 2.1.1 for iOS and Android.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and Canada
  • Product Description
    Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 || The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data
  • 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