Events

Notificaciones De Seguridad De Campo acerca de cobas u

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 Diagnostics.

¿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
    With this notification we would like to inform you about the possible contamination of cuvettes of cobas u cuvette with small plastic particles. when used on cobas u 701 microscopy analyzer, these particles will be recognized as bacteria by the analyzer. hence, a false positive result for the parameter bacteria (bac) is the potential consequence. this can lead to wrong diagnosis of asymptomatic bacteriuria. in the worst case, a treatment decision can be made based on erroneous positive results for bacteria in urine. only lot 16483701 was reported as affected. roche diagnostics received one customer complaint regarding this issue. .

Device

cobas u

Manufacturer

Roche Diagnostics