Events

Medtronic Paradigm Insulin Pump 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-2013-RN-00267-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-03-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00267-1
  • 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
    Issue 1: loose drive support cap – if the loose drive support cap is pressed on, it could result in the unintended delivery of additional insulin.Issue 2: sensor graph timeout (only affects paradigm veo (mmt-554 and mmt-754)) – this issue could prevent the auto-resume of basaldelivery 2-hours after a low glucose suspend event, which can result in elevated blood glucose values.Issue 3: water damage– this issue may result in a pump alarm or cause the buttons to stop working.
  • 조치
    Issue 1: Medtronic is asking consumers to regularly examine the pump especially after a shock or drop on a hard surface. If the drive support cap is sticking out, customers are asked to not press on this portion of the pump and to discontinue the use of the pump. Customers will need to manage their diabetes as per the back-up plan provided to them by their healthcare professional. Also, contact Medtronic 24 hour Helpline on 1800 777 808 (option 1). Issue 2: Medtronic is providing work around instructions to prevent this issue from occurring. Issue 3: Medtronic is asking customers to follow the user guide to prevent this issue from occurring.

Device

Medtronic Paradigm Insulin Pump

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