Events

RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series Analysers (diagnostic blood gas analyser) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-01001-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-09-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01001-1
  • 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
    According to reports received by siemens, users can inadvertently enter a wrong patient id on the demographics screen, which ultimately could lead to a misidentification of the sample. patient id mismatches could be caused by the following:1. inadvertently accepting the pre-selected patient id on the demographics screen.2. overwriting sample demographics by incorrect operation of the patient list button.3. scanning the wrong barcode.4. manually typing the wrong barcode.In each of these cases, failure to check the correct demographics before moving on to the results screen will assign the wrong demographics to the sample being tested.
  • 조치
    Siemens is providing work around instructions for users to follow in the event that patient ID mismatch occurs. A software update will be available for RAPIDPoint 400 series and RAPIDPoint 500 analysers in January 2014. Software version 3.2 and over which are currently available for RAPIDLab 1200 Series analyser addresses the issues. This action has been closed-out on 28/04/2016.

Device

RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series Analysers (diagnostic blood gas a...
  • 모델명 / 제조번호(시리얼번호)
    RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series Analysers (diagnostic blood gas analyser)ARTG Number: 174383
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division