Events

Paradigm ambulatory insulin infusion 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 연번
    MDA/2014/019
  • 날짜
    2014-05-29
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-paradigm-ambulatory-insulin-infusion-pumps-risk-of-hypoglycaemia
  • 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
    Risk of hypoglycaemia due to incorrect selection and delivery of bolus amount.Medtronic has received reports of users accidentally programming the pump to deliver the maximum bolus amount.
  • 원인
    (medtronic) risk due to incorrect selection and delivery of bolus amount. (mda/2014/019).
  • 조치
    Identify affected pumps.Ensure that all staff and patients receive the relevant copy of Medtronic’s Field Safety Notice (FSN) dated March 2014 and follow the recommendations.In particular:When programming insulin doses through the ‘Main Menu’, be aware that scrolling down allows the dose displayed on the screen to go from 0.0 units to the maximum programmed insulin dose. Always confirm that the insulin dose flashing on the display screen is correct before starting delivery. Make sure the ‘Max Bolus’ and ‘Max Basal’ settings are programmed according to individual insulin needs as determined by the healthcare professional.

Device

Paradigm ambulatory insulin infusion pumps
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Paradigm ambulatory insulin infusion pumps.Manufactured by Medtronic.Models: MMT- 511, 512, 712, 712E, 515, 715, 522, 522K, 722, 722K, 523, 523K, 723, 723K, 554, and 754.
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 제조사 주소
    Lezlie Bridge Regulatory Affairs Manager, UK & Ireland Medtronic Limited Building 9 Croxley Green Business Park Watford WD18 8WW Tel:    01923 212 213 Fax:  01923 225 273Email: lezlie.j.bridge@medtronic.com
  • 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