CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD). MiniMed Paradigm insulin infusion pumps, MiniMed NGP Pumps, MiniMed Guardian Monitor REAL-Time and CONTOUR NEXT test strips. 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bayer Australia 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-00746-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-08-27
  • 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
    Contour next control solutions. in vitro diagnostic medical device (ivd)contournext control solutions are used with contour next test strips andcontournext family meters (contour xt/next ez, contour next, contour next link, contour next link 2.4, contour next usb), medtronic minimed paradigm insulin infusion pumps, minimed ngp pumps medtronic minimed guardian monitor real-time . all lots of control solution are affectedartg number: 191635.
  • 조치
    Bayer is notifying healthcare professionals of changes to the instructions for use. The additional instructions provide detailed information on the proper handling of Contour Next controls. Bayer is also notifying health care professionals that if a CONTOUR NEXT control test result is outside of the control range, make sure to follow the instructions above, and perform another control test.

Device

  • 모델명 / 제조번호(시리얼번호)
    CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD).MiniMed Paradigm insulin infusion pumps (MMT- 512, MMT-712, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT- 523, MMT523K, MMT-723, MMT-723K, MMT-551, MMT-751, MMT-554 and MMT-754), MiniMed NGP Pumps (MMT-1510, MMT-1511, MMT-1512, MMT-1580, & MMT- 1712), MiniMed Guardian Monitor REAL-Time (CSS7100 & CSS7200) and CONTOUR NEXT test strips. All lots of control solution are affected.
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA