Notificaciones De Seguridad De Campo acerca de RPD / ClinChem fully automated

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Roche.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2015-03-10
  • País del evento
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Customers complained about a 20% decrease in control levels when using non-roche controls (e.G. thermofisher liqimmune) with homocysteine reagent lot 697811 on cobas c 501. after changing to lot 604303, the controls were within range. the comparison of patient samples with reagent lot 697811 vs 604303 showed a bias of up to 54%. edta plasma samples were used. this negative bias could, in the worst case, lead to inaccurately low homocysteine results. however, it is unlikely that inaccurately low homocysteine results would lead to an immediate adverse event, since it has been demonstrated that homocysteine is a predictor of long-term (late cardiac events), rather than short-term cardiovascular risk. .

Device

  • Modelo / Serial
    05 385 415 190 Lot No.: 69781101 06 542 921 190 Lot No.: 69781401 05 385 377 190 Lot No.: 69780301
  • Manufacturer

Manufacturer