Events

Recall of Accu-Chek Connect diabetes management app – Bolus Advisor function

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diabetes Care Australia Pty Ltd.

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
    RC-2017-RN-00410-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00410-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    A software issue has been identified in the accu-chek connect diabetes management app versions 2.0.0, 2.0.1, and 2.1.0 (ios & android). under certain conditions, the affected app versions may cause the bolus advisor to reset and display an incorrect active insulin amount of 0.0 on the app’s home screen, which may lead to an incorrect bolus advice. no warning message is displayed to the user. depending on the individual patient’s metabolic situation, a potentially incorrect bolus advice could result in serious health consequences (e.G. hypoglycaemia). (please note that previous versions of the app are not affected by this software issue. no other roche product with a bolus advisor is affected. also, all other functions on the accu-chek connect app can still be used.).
  • Action
    Roche Diabetes Care is requesting healthcare professionals to notify their patients to whom the Accu-Chek Connect diabetes management app bolus advisor has been prescribed, and advise them to discontinue using the bolus advisor function. Roche is advising users that an updated version is being developed and they will be informed once it is available. Consumers with the affected app versions are advised to liaise with their healthcare professional for further advice.

Device

Accu-Chek Connect diabetes management app – Bolus Advisor function
  • Model / Serial
    Accu-Chek Connect diabetes management app – Bolus Advisor function Versions 2.0.0, 2.0.1, 2.1.0 (iOS & Android)ARTG Number: 224385
  • Manufacturer
    Roche Diabetes Care Australia Pty Ltd

Manufacturer

Roche Diabetes Care Australia Pty Ltd