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
    79001
  • Event Risk Class
    Class 2
  • Event Number
    Z-0625-2018
  • Event Initiated Date
    2017-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161061
  • 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. due to a software bug, when the os region of the phone setting is changed, the unit of measure within the app may unexpectedly change. this creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.
  • Action
    On 06/13/2017, Roche Diabetes Care, Inc. made the Urgent Medical Device Correction notice available to their customers through the Accu-Chek.com website and through the Accu-Chek Connect microsite. Patients are instructed to: Update to version 2.1.1 of the Accu-Chek Connect app Clear all data from the 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 the 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 the 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 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 your meter via micro-USB cable. 6. Follow the onscreen instructions to upload your data and clear your meter. If you use the apps Bolus Advisor feature, please carefully review and manage your active insulin and insulin bolus amounts for the first 8 hours after initial installation of the app and pairing your meter. This ensures the software will establish an accurate history for use in future bolus recommendations. They are advised to contact Accu-Chek Customer Care at 1-800-688-4578 if there are additional questions.

Device

Device Recall AccuChek Connect Diabetes Management App
  • Model / Serial
    Software Versions: 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, and 2.1.0
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide
  • Product Description
    Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
  • 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