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