Events

Safety Alert for accu-chek spirit combo insulin pumps

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Roche Diagnostics.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-10-03
  • Event Date Posted
    2014-10-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141003a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: roche diagnostics accu-chek spirit combo insulin pumps the australia therapeutic goods administration (tga) posted a medical device safety alert concerning accu-chek spirit combo insulin pumps manufactured by roche diagnostics. the manufacturer 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. investigation of the situation 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. the manufacturer 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 manufacturer to arrange for a replacement pump. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01063-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 03 october 2014.

Device

accu-chek spirit combo insulin pumps
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Roche Diagnostics Accu-Chek Spirit Combo Insulin Pumps
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics