Events

Animas 2020 and Animas IR 1200 Insulin Pumps 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Australasian Medical & Scientific 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-2015-RN-00363-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-05-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00363-1
  • 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
    Animas has identified a software limitation included in the animas 2020 and animas 1200 insulin pumps. the software included in the animas 2020 insulin pump only operates until midnight on dec. 31, 2015. after this date, the pump will no longer deliver insulin and will generate a call service alarm. this end of use date is not currently included in our product labelling. the calendar software included in the animas 1200 will not recognise and store any date in 2016 or beyond. after midnight on dec. 31, 2015, the pumps’ calendars will revert to a previous year. this calendar issue is not currently included in our product labelling. although these pump models will continue to deliver insulin, if patients are using a data management software program with their pump, they will notice inaccuracies in the reports because of the incorrect dates.
  • 조치
    AMSL is replacing 2020 and IR 1200 pumps which are still in use with a new model Aminas Vibe Insulin Pump. This action has been closed-out on 24/08/2016.

Device

Animas 2020 and Animas IR 1200 Insulin Pumps

Manufacturer

Australasian Medical & Scientific Ltd