Events

Recall of Accu-Chek Mobile Blood Glucose Meter

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-00592-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00592-1
  • 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 diagnostics has identified that a small number of people with diabetes using the accu-chek mobile device have experienced falsely elevated blood glucose readings when using the system as a result of not following the described and labelled handling instructions. such improper handling can include, for example, unclean hands contaminated with glucose-containing substances, pressing the finger too hard and too long on the test field or smearing the blood while performing a test. roche has decided to enhance its training and handling instructions for the accu-chek mobile system – increasing their visibility in the meter kit to ensure people with diabetes’ understanding of how to appropriately use the system. this will enable the users to obtain safe and reliable blood glucose (bg) readings at all times.Br /br /the tga has published a web statement regarding this issue. for more information, pleaser refer to: http://www.Tga.Gov.Au/safety/alerts-device-accu-chek-glucose-meter-140606.Htm.
  • Action
    Consumers are advised to continue to use their Accu-Chek Mobile device safely and reliably by carefully following the instructions that are described in the User Manual and which can also be found in a new instructions leaflet available at www.accu-chek.com.au. Specifically: · Wash your hands with warm water and soap. Dry your hands thoroughly before obtaining a blood sample. · Form a proper blood drop and apply it to the centre of the test field. · Immediately apply the blood gently to the test field after you have created the blood drop. · Do not press against the test field on the tape. · Touch the test area gently and your finger should be removed from the test field when the beep tone sounds and/or “test in progress” is displayed.

Device

Accu-Chek Mobile Blood Glucose Meter

Manufacturer

Roche Diagnostics Australia Pty Limited