Events

Retiro De Equipo (Recall) de Stratus CS Acute Care Diagnostics System. 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 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-2016-RN-00867-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-06-29
  • 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-2016-RN-00867-1
  • 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 has identified a software defect in the stratus cs acute care diagnostics system regarding testpak calibration and quality control (qc) status when a testpak is due to expire within 48 hours. depending on the calibration status, either an above assay range (aar) or an inaccurate value could potentially be reported when running a testpak that is due to expire within 48 hours. the probability of occurrence is extremely unlikely and other factors such as previous results, patient presentation, and other diagnostic testing would initiate clinical questioning and reduce the potential for injury.
  • Acción
    Siemens Healthcare is advising users of the following: 1. Do not use TestPaks that are due to expire within 48 hours, OR 2. Check Reagent Status to ensure all TestPaks in use have valid calibration expiry dates beyond the TestPak lot expiry date, AND 3. If the laboratory performs routine QC and if using a TestPak that is due to expire within 48 hours, ensure that scheduled QC is performed before running a test. Siemens Healthcare is currently developing software updates to address this issue and will be providing new information as it becomes available.

Device

Stratus CS Acute Care Diagnostics System. An in vitro diagnostic medical device (IVD).

Manufacturer

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