Events

MiniMed 640G Insulin Infusion 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-2017-RN-00661-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-06-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00661-1
  • 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
    Medtronic has identified an issue that may potentially affect the minimed 640g insulin infusion pump. keypad buttons on the minimed 640g series insulin pumps may become temporarily unresponsive when the atmospheric pressure around the pump increases or decreases rapidly. this would most likely happen when travelling in an airplane during take-off or landing.During this temporary situation, a button may be too difficult to press down or a button can look like it is physically pressed down and stuck in that position. if patients notice the keypad buttons are difficult to press down, the pump will continue to deliver basal insulin. patients may not be able to program a bolus or suspend delivery as the buttons temporarily will not press down, but this will resolve on its own, usually within 30 minutes.
  • 조치
    Users are advised that If they experience this temporary keypad condition, and want to resolve it immediately to bolus or clear the alarm: Remove the battery cap from the pump and then place it back on. A fresh new AA battery should be available in the event the pump prompts users to insert a new battery. In the short term an errata sheet will be provided with new devices until such time as this information can be permanently incorporated into the Instructions for Use (IFU).

Device

MiniMed 640G Insulin Infusion 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