Events

Retiro De Equipo (Recall) de ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems (An in vitro diagnostic medical device (IVD))

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 Ltd Diagnostics Division.

¿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-2014-RN-00925-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-22
  • 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-2014-RN-00925-1
  • 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 an issue that causes patient demographics data (patient name, age, sex) from the previous order received from the laboratory information system (lis) to be merged with the next order. this issue can occur when the lis data buffer on the advia centaur system becomes full and a particular character (h) is found in the last five locations in the lis data buffer. in this case, the incorrect patient demographic information will be transmitted to the lis and will be displayed on the advia centaur user interface and instrument generated printed reports.
  • Acción
    If the ADVIA Centaur and / or ADVIA Centaur XP Immunoassay System is interfaced to a LIS system that transmits patient demographics with each order, the customers are advised to check the event log for the message: “500 03 01 Unknown format message” / rejected results on the LIS. If the message is present, customers are advised to review patient demographic information for all work orders after the time of this event to identify any specific ranges defined for age or sex apply to the order and ensure necessary action is taken for this result.

Device

ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems (An in vitro diagnostic medical device (IVD))
  • Modelo / Serial
    ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems (An in vitro diagnostic medical device (IVD))ADVIA Centaur Immunoassay SystemSiemens Material Number: Multiple ADVIA Centaur XP Immunoassay SystemSiemens Material Number: MultipleARTG Number: 175890
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA