Events

Notificaciones De Seguridad De Campo acerca de MULTIGENT Creatinine (Enzymatic) 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 Sentinel CH Spa.

¿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
    2017-05-22
  • 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
    Sentinel has detected a performance issue with the reagent 1 component of the three impacted lots listed above. this issue may result in quality control values shifting out of acceptable range, which is not resolved by recalibration. only replacement of the impacted lots with a new lot resolves the issue. in addition, some customers have reported erratic patient results. the investigation has determined that this issue is isolated to the 3 impacted lots listed above. the corrective and preventive actions already in place will avoid any future recurrence. .

Device

MULTIGENT Creatinine (Enzymatic) assay
  • Modelo / Serial
    lots 60335Y600, 60382Y600 and lot 60334Y600
  • Manufacturer
    Sentinel CH Spa

Manufacturer

Sentinel CH Spa