Events

Medtronic MiniMed Infusion Sets MiniMed Quick-set MiniMed mio MiniMed Silhouette MiniMed Sure-T 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-01182-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-09-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01182-1
  • 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 become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. over-delivery of insulin can cause hypoglycaemia and in extreme cases, death. medtronic has received reports of hypoglycaemia requiring medical intervention potentially related to this issue. out of the millions of infusion sets sold each year, the reported incident rate requiring medical assistance related to this issue is less than 0.00005%. there have been no reports of death related to this issue.An investigation by medtronic has shown this issue can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. a membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on the top of the reservoir or inside the tubing connector which then could prevent the infusion set from working properly.
  • 조치
    For patients: 1. Users and HCPs with affected lot numbers (as confirmed with Medtronic using the dedicated webpage https://checklots.medtronicdiabetes.com or Global Help Line 1800 777 808) are to cease using the sets and, in the absence of unaffected alternatives, follow the steps contained in the supplied letter. Medtronic will replace the affected sets free of charge. 2. Cut out the bar codes on the boxes of recalled infusion sets (as per supplied picture) and return the bar codes in the reply paid envelopes that will be sent out with the new infusion sets. 3. Users are to discard, not return, the affected sets. 4. Customers are also requested to complete and sign the supplied Acknowledgment Form, and return as directed to Medtronic Australasia. For further information, please see https://www.tga.gov.au/alert/medtronic-minimed-infusion-sets

Device

Medtronic MiniMed Infusion Sets MiniMed Quick-set MiniMed mio MiniMed Silhouette MiniMed Sure-T
  • 모델명 / 제조번호(시리얼번호)
    Medtronic MiniMed Infusion SetsMiniMed Quick-setMiniMed mioMiniMed SilhouetteMiniMed Sure-TARTG Number: 119216
  • 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