AQURE Data Management System, Version 1.54. An in vitro diagnostic medical device (IVD) 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-2013-RN-01318-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-12-13
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    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.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
    AQURE Data Management System, Version 1.54. An in vitro diagnostic medical device (IVD)
  • Manufacturer

Manufacturer