Events

Animas IR1200, Animas IR1250 and Animas 2020 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Animas 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/2013/003
  • 사례 연번
    CON226927
  • 날짜
    2013-01-22
  • 사례 출판 날짜
    2013-01-22
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON226927?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
    The pumps will only operate until 31 december 2015 due to a software problem. from 1 january 2016 the pumps will not deliver insulin and will generate a call service alarm. the manufacturer has stated that this software issue will not affect pumps prior to 1 january 2016. further information is available in the manufacturer’s field safety notice (fsn) dated 12 november 2012.
  • 조치
    Identify affected devices. Ensure that staff and patients who are affected are aware of this problem. Contact the manufacturer to arrange for replacement pumps.  Please note that they will only be providing free-of-charge replacements for pumps that are within warranty. Ensure that all affected pumps are replaced before 31 December 2015. Diabetes departments Pharmacists Those involved in the procurement, supply and use of this device.

Device

Animas IR1200, Animas IR1250 and Animas 2020
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Ambulatory insulin infusion pumps. Animas IR1200, Animas IR1250 and Animas 2020. All serial numbers . Animas no longer distributes the IR1200, IR1250 or the 2020 models in the UK. Affected pumps will be replaced with a different model of Animas insulin infusion pump. Animas will be providing training on the use of the replacement pumps. The manufacturer considers pumps that are outside the warranty period to have exceeded their expected life, and so will only be providing free-of-charge replacements for pumps that are still within warranty on 31 December 2015. Please note that all IR1200 and IR1250 pumps will be out of warranty by 31 December 2015.
  • Manufacturer
    Animas

Manufacturer

Animas