Events

Notificaciones De Seguridad De Campo acerca de CentraLink® Data Management System

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 Siemens Healthcare Diagnostics Inc..

¿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
    Siemens healthcare diagnostics has determined that there is a remote possibility centralink may download an order to the advia automation system without specifying the sample type. this can occur when an order is received from the lis without a sample type, requiring that the sample type be set in centralink based on the sample type of the test in the order. if the automated task to download samples to the laboratory automation system (las) processes immediately after the order is received from the lis, there is a possibility that a test may be downloaded before the sample type on the sample record is set. on advia automation, the value “default” will be downloaded instead of the sample type value. due to the timing required, the frequency of occurrence has been determined as less than one in a million. .

Device

CentraLink® Data Management System
  • Modelo / Serial
    CentraLink Data Management System, Software Versions: v13x,v14x,v15x 10485061, 10484212, 10485064, 10483439, 10471393, 10484552, 10814296, 10815474, 11220480, 10481936, 10481937, 10481938, 10482170, 10482936, 10483437, 10483438, 10483440, 10484211, 10484213, 10485060, 10485062, 10485063, 10703007, 10703008, 10711638, 10711639, 10711640, 10711641, 10711643, 10811596, 10811597, 10811598, 10811599, 10811601, 10811741, 10811742, 10811743, 10814298, 10814877, 10814880, 10814881, 10815694, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10817180, 10817181, 10819760, 10819943, 11219840, 11219841
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    AMPMDRS