Events

Rappel de AQURE data management system

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-2016-RN-00015-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-06
  • 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-2016-RN-00015-2
  • 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
    There is a potential clinical issue with aqure if the data management system is being used to interpret patient results for the management of treatment. the issue occurs when a sample type is not provided from a device. an example is where results from a sample type of “urine” (not displayed) are compared to results from a sample type “arterial”. in this case a clinician may incorrectly take action based on an assumption that all results are from a sample type “arterial”. this may lead to wrongful diagnosis and wrongful treatment of the patient which can result in immediate as well as long term critical health consequences for the patient.
  • Action
    The sponsor will contact the affected customers to arrange for the installation of a database script which will mitigate the risk as a temporary measure. A final solution involving a software upgrade will be provided to the customers when it becomes available. In the meantime, the AQURE system can continue to be used but users are advised to interpret blank fields for sample type as "not specified".

Device

AQURE data management system

Manufacturer

Radiometer Pacific Pty Ltd