Events

Animas Insulin Infusion Pump (ambulatory insulin infusion pump) 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-2012-RN-00690-3
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-07-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00690-3
  • 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
    Some patients experienced gradual wear of their insulin pump keypad that led to damage such as tearing or peeling of the edge of the keypad from the insulin infusion pump. the buttons may not respond as intended. the potential hazard is that it may cause the pump to malfunction and may cause under infusion or over infusion of insulin, resulting in hyperglycaemia or hypoglycaemia respectively.
  • 조치
    Customers are requested to examine their insulin pump keypad for wear or damage on a regular basis, as part of the routine process of inspecting the pump. The Sponsor will replace any pumps that have a confirmed issue with the keypad.

Device

Animas Insulin Infusion Pump (ambulatory insulin infusion pump)
  • 모델명 / 제조번호(시리얼번호)
    Animas Insulin Infusion Pump (ambulatory insulin infusion pump), models - IR 2020, 1200ARTG Number: 96120
  • Manufacturer
    Australasian Medical & Scientific Ltd

Manufacturer

Australasian Medical & Scientific Ltd