Events

Safety Alert Or Field Safety Notices for cobas b 221 instruments with AutoQC module

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Roche Diagnostics GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2018-05-01
  • Event Date Posted
    2018-05-01
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/cobas-b-221-instruments-with-autoqc-module-software-limitation-affecting-automatic-qc-measurements
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
    The cobas b 221 instruments are point of care systems used for the determination of multiple blood gas and metabolic parameters, as well as electrolytes. Automated QC measurements may be used to ensure system validity. The reported software limitation issue affecting automatic QC measurements does not directly impact patient results. However, the absence of quality control results may lead to erroneous patient results caused by an unrelated system issue to remain undetected. Erroneous patient results (high, normal, or low) may lead to wrong or delayed diagnosis and/or treatment.
  • Reason
    Manufactured by roche diagnostics gmbh – under specific circumstances scheduled automatic qc measurements may no longer be performed and erroneous patient results may remain undetected.
  • Action
    Identify affected devices, which are listed in the manufacturers Field Safety Notice (FSN) Ensure that all relevant members of staff receive the manufacturers FSN and that they understand the problem and actions to be taken. Follow the manufacturers workaround until the planned software patch is available and has been installed. If any adverse event occurs relating to this issue please report this to MHRA via Yellow Card or the relevant devolved administrations (Scotland, Wales and Northern Ireland).

Device

cobas b 221 instruments with AutoQC module

Manufacturer

Roche Diagnostics GmbH
  • Manufacturer Address
    Roche Diagnostics Ltd Charles Avenue Burgess Hill West Sussex RH15 9RY Registration number: 571546Technical Support Hotline UK: 08081001920Email: burgesshill.technicalenquiry@roche.com
  • Manufacturer Parent Company (2017)
    Roche Holding Ag
  • Source
    MHRA