Events

Riata and Riata ST – all silicone coated models 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 St Jude Medical 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/2014/009
  • 사례 연번
    CON392815
  • 날짜
    2014-03-13
  • 사례 출판 날짜
    2014-03-13
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON392815?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
    These blood glucose meters may give incorrect low blood glucose results when they are used with freestyle lite and freestyle blood glucose test strips. abbott diabetes care is therefore asking people to stop using these affected meters and to contact them to get a replacement. the manufacturer has sent field safety notices, dated 19 february 2014, to customers. to deal with this problem when using freestyle navigator continuous glucose monitoring system (1.0 and 1.5 generation) and the freestyle blood glucose meter built into the omnipod insulin management system, follow the advice in the manufacturer’s field safety notice.
  • 조치
    Advise users to contact Abbott Diabetes Care customer services on 0500 467 466. Pharmacists supplying FreeStyle Lite and FreeStyle blood glucose test strips: When dispensing test strips advise users to contact Abbott Diabetes Care customer services for a replacement meter. Healthcare professionals managing patients: Advise users to contact Abbott Diabetes Care customer services for a replacement meter. This Medical Device Alert replaces MDA/2013/082R. Pharmacists supplying FreeStyle Lite and FreeStyle blood glucose test strips to patients who use the affected devices.

Device

Riata and Riata ST – all silicone coated models
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Implantable cardioverter defibrillator (ICD) leads. Riata and Riata ST – all silicone coated models.
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    MHRA