Events

Rappel de AQURE Data Management System, Version 1.54. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Radiometer Pacific Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-01318-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01318-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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)
  • Modèle / numéro de série
    AQURE Data Management System, Version 1.54. An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd