Events

Recall of Accu-Chek Spirit Combo insulin pump

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-00576-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00576-1
  • 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
    There is an increased risk that the vibration alarm will not work, as a result of a changed component. this fault will only be detected at pump start up, when it will display an ‘e-7’ error message and give an audible signal, but will fail to start. safety features such as the continuing audio signal as well as a visual notification will enable the user to detect the issue immediately and thus prevent from using an incorrectly functioning device.Br /br /the tga has published a web statement regarding this issue. for more information, please refer the following link: http://www.Tga.Gov.Au/safety/alerts-device-accu-chek-insulin-pump-140606.Htm.
  • Action
    Roche is advising Accu-Chek Spirit Combo users of the potential for frequent E7 errors and reinforcing the instructions on how to clear the error. If the E7 error occurs repeatedly users are requested to contact Roche for a replacement device. This action has been closed-out on 10/02/2016.

Device

Accu-Chek Spirit Combo insulin pump

Manufacturer

Roche Diagnostics Australia Pty Limited