Events

GlucoMen LX Sensor blood glucose test strips 50 count used with the GlucoMen LX and GlucoMen LX PLUS meter 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Menarini 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/2013/064
  • 사례 연번
    CON303150
  • 날짜
    2013-08-14
  • 사례 출판 날짜
    2013-08-14
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON303150?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
    Affected lots have been contaminated during manufacture, and may give an overestimation of blood glucose levels, potentially resulting in inappropriate insulin administration. the manufacturer distributed the affected lots in the uk via wholesale outlets during october and november 2012. the product may, however, still remain with users or pharmacies. there is currently no evidence that uk patients have been affected.
  • 조치
    Identify and quarantine affected lots. Identify patients using these meters and advise them that they should return and not use strips from the affected lots. Ensure that users who return strips from the affected lots can continue to monitor their blood glucose. Contact Menarini to arrange the return of any strips from the affected lots.

Device

GlucoMen LX Sensor blood glucose test strips 50 count used with the GlucoMen LX and GlucoMen LX P...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Home use blood glucose test strips GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter manufactured by Menarini. Lot 3212214249, expiry date 31-08-2014 and lot 3212219249, expiry date 31-08-2014. Illustration of tub, containing 50 test strips.
  • Manufacturer
    Menarini

Manufacturer

Menarini