Events

Recall of Accu-Chek Spirit Combo Insulin Pumps

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-01063-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-10-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01063-1
  • 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 that in a limited number of cases, patients using the accu-chek spirit combo insulin pump may experience a loss of the date and time settings. investigations undertaken by roche revealed that this issue may occur if the pump capacitor fails to function properly due to a leakage. the capacitor provides the necessary voltage to save time and date settings during power interruption, typically during a battery change.
  • Action
    Roche is advising end users and healthcare professionals of the potential issue. End users are advised to ensure that the time and date are set correctly after a battery change. Users who experience any failures are requested contact the Accu-Chek Customer Care Line to arrange for a replacement pump. For more details, please see http://www.tga.gov.au/safety/alerts-device-accu-chek-insulin-pump-141003.htm This action has been closed-out on 18/08/2016.

Device

Accu-Chek Spirit Combo Insulin Pumps

Manufacturer

Roche Diagnostics Australia Pty Limited