Events

Retiro De Equipo (Recall) de RAPIDPoint 500 Measurement Cartridges. 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-00601-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-06-03
  • 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-00601-1
  • 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 received several reports from customers of one or more electrolyte parameters (e.G., na+, ca++, k+, cl-) reporting a “-----?” error code when aqc, qc, or cvm is run on the rapidpoint 500 blood gas analyzer. when exhibited, the issue is usually seen during level 1 qc /aqc, level 1 cvm, and sometimes level 2 cvm testing. this issue has also been observed on a small number of patient samples.
  • Acción
    Customers are advised that the following steps can be taken to mitigate the issue: - Install a RAPIDPoint 500 Measurement Cartridge or - Install a 405 Measurement Cartridge. Customers will need to arrange to get the lactate results from other instruments in their central laboratory since the Lactate parameter is not available on the RAPIDPoint 405 cartridge or - Use an alternative system to obtain the electrolyte values. Since this issue is not related to the AQC cartridge, installing a new AQC cartridge will not solve the problem.

Device

RAPIDPoint 500 Measurement Cartridges. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    RAPIDPoint 500 Measurement Cartridges. An in vitro diagnostic medical device (IVD)Part numbers: 10844813, 10491447, 10491448 & 10491449Serial Numbers: 2334500011 to 2412705915ARTG number: 176642
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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