Events

Recall of Accu-Chek Spirit Combo insulin pump and Accu-Chek Spirit insulin pump. An in vitro diagnostic medical device (IVD)

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-2015-RN-00347-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-04-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00347-1
  • 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 has become aware that some customers are experiencing an increase of mechanical errors with their insulin pumps showing e6 & e10 error messages. this is associated with handling of the cartridge during the cartridge change process. roche has improved the handling instructions for the cartridge change to prevent the future occurrence of this issue.If users do not follow the cartridge change process step-by-step as described in the updated handling instructions, there is a potential risk of small insulin amounts to drip into the cartridge compartment, and result in a damage of the piston rod over time, so that the piston rod will not properly move and potentially limit or cause a blockage of the insulin pump motor function. eventually, this may result in the insulin not being delivered as intended. the issue is easily detectable as the pump will alert the user by acoustic, visual & vibration alerts.
  • Action
    Roche is contacting all users and providing a training leaflet with step by step instructions to assemble the cartridge, adapter and infusion set tubing first, prior to inserting the new cartridge into the insulin pump. For more details, please see http://www.tga.gov.au/alert/accu-chek-spirit-combo-and-accu-chek-spirit-insulin-pumps . This action has been closed-out on 04/08/2016.

Device

Accu-Chek Spirit Combo insulin pump and Accu-Chek Spirit insulin pump. An in vitro diagnostic med...

Manufacturer

Roche Diagnostics Australia Pty Limited