Events

MiniMed 640G Insulin Infusion Pump (with software version 2.6) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-2017-RN-00167-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-02-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00167-1
  • 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
    A software issue affecting some minimed 640g insulin infusion pumps that could prevent the internal battery from charging has been identified. should this issue occur, an alarm will be triggered and users will see a "power error detected" message accompanied by the number “25”, displayed on the pump screen. users are advised not to ignore this alarm and error message, which means that their pump has now stopped delivering insulin. if not, users could develop high blood sugar levels (hyperglycaemia).
  • 조치
    Medtronic has contacted users who could potentially be affected and relevant health professionals to provide further information about this issue. Medtronic is advising users who experience this error to phone the Medtronic 24 hour Helpline (1800 777 808 - option 1). Users will be guided to troubleshoot to determine the cause of the error message and to perform a pump reset process which will reset the condition that caused the software anomaly. If the error cannot be corrected, the pump will be replaced. TGA will soon be publishing a web statement about this issue.

Device

MiniMed 640G Insulin Infusion Pump (with software version 2.6)
  • 모델명 / 제조번호(시리얼번호)
    MiniMed 640G Insulin Infusion Pump (with software version 2.6)ARTG Number: 95763
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA