Events

Safety Alert for cobas b 123 - neonatal bilirubin results with software sw4.7

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
    2016-11-29
  • Event Date Posted
    2016-11-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161129.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 cobas b 123 - neonatal bilirubin results with software sw4.7 the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning cobas b 123 analyser manufactured by roche diagnostics. the affected device identifiers are 05122279001, 05122287001 and 05064694001 with software version sw v4.7. during an investigation of a complaint, the manufacturer has become aware of a software issue that may cause discrepancies between neonatal bilirubin results obtained with cobas b 123 <3> and <4> systems running software version sw v4.7 compared to systems running software version sw v4.5. the deviations are mainly apparent at high bilirubin values. for the overall population, it is not likely that the differences in results at the medical decision point would lead to an incorrect medical treatment. in the worst case, it is most likely that the sample will be re-tested respectively when a second blood sample will be drawn. for population most at risk (newborns under 28 days, particularly premature neonates borne 23+ week of gestation), a medical risk cannot be excluded. incorrect medical decisions, due to discrepant results of bilirubin, at the medical decision point according to the threshold tables and the treatment threshold graphs, provided with pediatric guidelines for management of hyperbilirubinemia, cannot be entirely ruled out. according to the manufacturer, the software issue has already been corrected in cobas b 123 poc system software version sw v4.8. if an immediate update to software version sw v4.8 is not possible, workaround instructions when using software version sw v4.7 are included in the field safety notice. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-21-25-november-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 november 2016.

Device

cobas b 123 - neonatal bilirubin results with software sw4.7
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Roche cobas b 123 - Neonatal Bilirubin Results with Software SW4.7
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics