Events

Retiro De Equipo (Recall) de AQURE Data Management System, Version 1.54. 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 Radiometer Pacific 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-2013-RN-01318-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-13
  • 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-2013-RN-01318-1
  • 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
    Results which are repressed on the analyser are shown in aqure version 1.5.4 and forwarded to the his/lis. repression means that values flagged with errors (marked with "?") are not displayed on the analyser. the repressed results are forwarded to aqure and flagged, but dependant on the settings of the hospital it, the result may not be flagged in his/lis. the problem is present when the user has enabled the option 'repress results' on the analyser and uses aqure version 1.5.4.The results may not be flagged in his/lis and the user will therefore not be aware that the result may be incorrect. patient treatment or diagnosis could therefore be based on an incorrect result.An example:the abl90 analyser did not give a cl- result due to the error 1227 "correction for bicarbonate contains errors from ph, pco2". however the chloride result was displayed in the following way:on the analyser: blank (no value) and "?"aqure: 100mmol/l with "?" and highlighted redhis/lis: 100mmol/l.
  • Acción
    Radiometer is configuring the database of the AQURE system to ensure that all "?" marked results are blanked in AQURE and prior to transmitting to the HIS/LIS. Radiometer recommends a review of previous patient results with repressed parameter values in AQURE and HIS/LIS.

Device

AQURE Data Management System, Version 1.54. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    AQURE Data Management System, Version 1.54. An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd