Events

Insulin infusion sets and reservoirs used with Paradigm ambulatory insulin pumps 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Medtronic 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2013/070
  • 사례 연번
    CON309611
  • 날짜
    2013-08-28
  • 사례 출판 날짜
    2013-08-28
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON309611?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Risk of under- or over-delivery of insulin, which may lead to hypoglycaemia or hyperglycaemia, with a consequent loss of consciousness or death, in extreme cases. the root causes are: spillage from the insulin reservoir may block connector vents, preventing correct priming of the pump.  medtronic have issued advice on the correct technique for filling the reservoir. the insulin reservoir may leak, due to a manufacturing defect, which may result in under delivery of insulin and failure of the pump’s occlusion alarm. medtronic have initiated a recall of affected reservoirs.
  • 조치
    Identify affected infusion sets and reservoirs. Ensure that all relevant staff and patients receive the appropriate copy of Medtronic’s Field Safety Notices and are aware of the recommendations.  In particular: Ensure staff and patients follow the manufacturer’s recommendations to avoid spillage from the insulin reservoir. Discard unused, affected reservoirs immediately and request replacements.    Return Field safety Action sheet to manufacturer.

Device

Insulin infusion sets and reservoirs used with Paradigm ambulatory insulin pumps
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Insulin infusion sets and reservoirs used with Paradigm ambulatory insulin pumps (manufactured by Medtronic): Paradigm infusion sets (all MMT models, all lot numbers). Paradigm insulin reservoirs (MMT models - 326A and 332A, specific lots). See below for details of model and lot numbers for both products. Models of Paradigm infusion sets affected (all lots): MMT-317 MMT-318 MMT-324 MMT-325 MMT-312S MMT-312L MMT-386 MMT-387 MMT-394 MMT-396 MMT-397 MMT-398 MMT-399 MMT-377 MMT-378 MMT-381 MMT-382 MMT-383 MMT-384 MMT-368 MMT-862 MMT-864 MMT-866 MMT-874 MMT-876 MMT-884 MMT-886 MMT-921 MMT-923 MMT-925 MMT-941 MMT-943 MMT-945 MMT-961 MMT-963 MMT-965 MMT-975 Lot numbers of recalled MMT-326A and MMT-332A reservoirs: H8416432 H8461538 H8489386 H8512826 H8420977 H8463297 H8491921 H8515317 H8422490 H8464121 H8492449 H8517079 H8424676 H8467888 H8494645 H8521052 H8437486 H8469703 H8496561 H8539013 H8441420 H8471745 H8500423 H8541843 H8442973 H8473106 H8500472 H8584244 H8451531 H8473271 H8503372 H8627745 H8452933 H8476270 H8503728 H8603292 H8455959 H8478398 H8509305 H8604958 H8457716 H8485398 H8510440 H8635301 H8459557 H8486688 H8512566
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    MHRA