Events

Safety Alert for accu-chek spirit combo insulin pump

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
    2014-03-12
  • Event Date Posted
    2014-03-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140312.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 pump the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device alert concerning accu-chek spirit combo insulin pump, manufactured by roche diagnostics. the affected serial numbers are from 10171897 to 10281629 (inclusive). 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. there is a risk of treatment delay. the manufacturer advises users that: if a delay to insulin therapy could compromise patient safety, they should consider using an alternative device. when using these pumps, they should have a syringe or insulin pen available in case the pump stops. if the pump displays an ‘e-7’ error, they should contact local supplier for a replacement. for details, please refer to mhra websitehttp://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con392813 if you are in possession of the product, please contact your supplier for necessary actions. posted on 12 mar 2014.

Device

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

Manufacturer

Roche Diagnostics