Events

Alerta De Seguridad para cobas b 123 - neonatal bilirubin results with software sw4.7

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Roche Diagnostics.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2016-11-29
  • Fecha de publicación del evento
    2016-11-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161129.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche cobas b 123 - Neonatal Bilirubin Results with Software SW4.7
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics