Events

AQURE data management system 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Radiometer Pacific Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2016-RN-00015-2
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-01-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00015-2
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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