Events

Notificaciones De Seguridad De Campo acerca de cobas c 111 analyzer

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
  • País del evento
    Slovenia
  • 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
    We have become aware of a software issue that may lead to erroneous results on cobas c 111 analyzer (without ise unit) in very rare cases. cobas c 111 analyzer with ise unit are not affected as long as the ise is in status ‘ready’. to date, no field issue has been reported where the identified software error actually produced wrong results. under very rare constellations of already used and unused cuvettes remaining on the cobas c 111 analyzer rotor a measurement timing error “7002: 108000572 a software error occurred” might be produced. immediately after occurrence of the error all ongoing tests are stopped. depending on open test orders the system might restart processing using an already consumed cuvette and hence, producing a potentially erroneous result. we have identified measures to ensure the detectability for measurements that may have yielded erroneous results. .

Device

cobas c 111 analyzer
  • Modelo / Serial
  • Manufacturer
    Roche

Manufacturer

Roche