Events

Notificaciones De Seguridad De Campo acerca de ONLINE TDM Gentamicin assay

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
  • Fecha
    2016-05-23
  • 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
    Investigations have confirmed an increase in native patient sample result recovery of approximately 15-20 % when using online tdm gentamicin with recent preciset tdm i lots 615118, 619681, 126387, 140735. tdm controls and eqa (external quality assessment) samples also show an increased recovery of approximatively 15%. a combination with tdm control set lot 125783 does not show this effect. these observations were confirmed for the online tdm gentamicin reagent kits for use on cobas c and modular analytics

    comparing recovery with previous vs. recent preciset tdm i lots but also compared to gentamicin on cobas integra (gentm). the issue is most likely related to the preciset tdm i calibrator. based upon internal data the online tdm gentamicin reagent is showing an increased recovery. in .

Device

ONLINE TDM Gentamicin assay

Manufacturer

Roche Diagnostics