Events

All Accu-Chek® Insight insulin pumps 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
    2017-05-02
  • 사례 출판 날짜
    2017-05-02
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/all-accu-chek-insight-insulin-pumps-updated-information-for-battery-management
  • 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
    Note that this alert replaces and updates MDA/2015/029 which we published in August 2015.Roche has provided updated handling instructions and frequency for battery change to every 14 days from the 30 days previously recommended.
  • 원인
    Manufactured by roche diabetes care – replacement and update to mda/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.
  • 조치
    Identify all users of Accu-Chek Insight insulin pumps. Ensure that all patients and carers: Receive the manufacturer’s Field Safety Notice (FSN) understand the problem detailed in the FSN and follow the advice given by the manufacturer use Energizer® Ultimate lithium batteries (1.5V AAA / FR03) provided by the manufacturer and follow the steps described in the handling instructions in the FSN Contact Roche if you experience unexpected pump shut down or rapid battery depletion. Return the FSN acknowledgment form to Roche as currently the manufacturer hasn’t received enough responses.

Device

All Accu-Chek® Insight insulin pumps

Manufacturer

Roche Diabetes Care
  • 제조사 주소
    Roche Diabetes CareTel: 0800 731 2291burgesshill.insulinpumps@roche.comManufacturer FSCA Reference: SB_RDC_2017_04
  • 제조사 모회사 (2017)
    Roche Holding Ag
  • Source
    MHRA