Events

Recall of Accu-Chek Mobile Blood Glucose Monitoring System

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

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-2014-RN-00438-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00438-1
  • 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 become aware of a limitation of accu-chek mobile glucose tests, which may lead to erroneously lowered blood glucose readings in patients undergoing ceftriaxone therapy. this antibiotic substance is used to treat a variety of infections such as respiratory infections or lower urinary tract infections and is only administered intravenously or intramuscularly. the interference is due to the effect of this antibiotic on the measuring system of the device. this limitation is not described in the product labelling.
  • Action
    Roche Diabetes Care is advising users of this issue and update to the device's labelling. Patients with diabetes who are receiving therapy with ceftriaxone could be using the affected blood glucose monitoring (bGM) system. If this is the case then Roche is recommending customers to obtain an alternative bGM system for the duration of this therapy. For more details, please see http://www.tga.gov.au/safety/alerts-device-accu-chek-mobile-140422.htm .

Device

Accu-Chek Mobile Blood Glucose Monitoring System

Manufacturer

Roche Diagnostics Australia Pty Limited