Events

Retiro De Equipo (Recall) de ADVIA Centaur XPT System, with software versions V1.0.1, V1.0.2 and V1.0.3

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-01205-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-09
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01205-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare diagnostics has identified a number of issues that may affect the operation and workflow of the system.A summary of the issues is listed below. however this is not a comprehensive list. please refer to the customer letter for the full details.- if the assay is being run with multiple replicates defines, the analyser reports the results as a mean for all replicate results. this may lead to incorrect diagnosis. if the final result rule is disabled, it may lead to delayed diagnosis of hepatitis c viral infection or hiv. if the manual final result rule is being used with multiple replicates, it may lead to a missed diagnosis of toxoplasmosis. if you are running samples with replicates set to any value greater than 1, siemens recommends a look back of all results that may be affected.- if there is a unit change in test definition for assay & the delta check functionality is enabled, it may lead to incorrect flagging.
  • Acción
    Siemens is advising users that a number the issues may be corrected with software upgrade V1.1. The remaining issues will be corrected in a future software update, and Siemens is providing work around instructions as a interim measure. Siemens is recommends a lookback of patient results if users are running samples with replicates greater than 1 and discussing the customer letter with the Laboratory Director.

Device

ADVIA Centaur XPT System, with software versions V1.0.1, V1.0.2 and V1.0.3
  • Modelo / Serial
    ADVIA Centaur XPT System, with software versions V1.0.1, V1.0.2 and V1.0.3Siemens Material Number (SMN): 10711433Software version 1.0.1Bundle: 1.0.912 SMN: 10819704Software version 1.0.2Bundle: 1.0.1086 SMN: 11219806Software version 1.0.3Bundle: 1.0.1108 SMN: 11220781ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA