Events

Accu-Chek Mobile meter and Accu-Chek Mobile test cassette 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Roche 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/2014/021
  • 사례 연번
    CON425103
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON425103?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
    This device may give falsely high readings. as a consequence, patients might take an inappropriately high dose of insulin. the meter uses strip-free technology so users need to follow a specific testing procedure that is different to standard meter and strip systems. roche has sent its field safety notice (fsn), with updated instructions, to registered patients, healthcare professionals, distributors and retailers. the instructions are also online: www.Accu-chek.Co.Uk/mobilepropertesting (external link) this meter has been distributed in the uk since 2010.
  • 조치
    Identify patients who use these meters and advise them to follow the correct testing procedure, details of which have been provided in the FSN. Ensure that patients can continue to monitor their blood glucose. If patients are concerned about their blood glucose readings when using this meter, advise them to contact their healthcare professional.

Device

Accu-Chek Mobile meter and Accu-Chek Mobile test cassette
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Home use blood glucose meters. Accu-Chek Mobile meter and Accu-Chek Mobile test cassette manufactured by Roche.
  • Manufacturer
    Roche

Manufacturer

Roche