Events

Accu-Chek® Insight Insulin pump system 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 Diabetes Care 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
  • 날짜
    2016-09-01
  • 사례 출판 날짜
    2016-09-01
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/accu-chek-insight-insulin-pump-system-risk-of-over-or-under-infusion-of-insulin
  • 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
    Manufactured by roche diabetes care - inadequately detailed handling instructions of the 'key lock' function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of health e.G. hypoglycaemia or diabetic ketoacidosis.
  • 조치
    Identify users of the Accu-Chek Insight insulin pump system. Healthcare professionals should ensure that: patients/carers understand that the Quick Bolus keys on the top of the Accu-Chek Insight insulin pump are NOT locked by the Key Lock function patients/carers receive a copy of manufacturer’s Field Safety Notice (FSN), and are made aware of the enhanced handling instructions all new patients/carers have a copy of the FSN with their Accu-Chek Insight pump system. GPs should note that this is for their information only.

Device

Accu-Chek® Insight Insulin pump system

Manufacturer

Roche Diabetes Care
  • 제조사 주소
    Roche Diabetes Care Accu-Chek Pump Care Line Telephone: 0800 731 22 91Email: burgesshill.insulinpumps@roche.comManufacturer FSCA Reference: SB_RDC_2015_05
  • 제조사 모회사 (2017)
    Roche Holding Ag
  • Source
    MHRA