Events

Recall of Accu-Chek Connect Diabetes Management App for iPhone (iOS) v1.2.0(.5) (used in conjunction with Roche Accu-Chek Avica Connect and Accu-Chek Guide Blood Glucose Meters).

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-2016-RN-01168-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-09-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01168-1
  • 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
    Roche diabetes care has identified a programming error in the accu-chek connect diabetes management app ios version 1.2.0(.5) which under certain conditions could potentially lead to an inaccurate bolus insulin advice being provided to the patients. as a result of this issue the app “lightbulb” icon is not displayed and the correction bolus advice is not available.. the blood glucose (bg) value which could not be used initially may unintentionally become available for bolus advice calculation at a later time. if the patients then request a bolus advice for a bg value older than 10 minutes without taking and transferring a new bg measurement, it could lead to an incorrect bolus insulin recommendation. depending on the actual metabolic situation a potentially incorrect bolus advice could lead to serious health consequences.
  • Action
    Roche is advising Health Care Professionals to inform their patients by distributing a copy of the letter, to whom the Accu-Chek Connect diabetes management app has been distributed. Patients are being advised to discontinue using version 1.2.0.5 and update their app immediately to version 1.2.2.2. This action has been closed-out on 12/05/2017.

Device

Accu-Chek Connect Diabetes Management App for iPhone (iOS) v1.2.0(.5) (used in conjunction with R...

Manufacturer

Roche Diabetes Care Australia Pty Ltd