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
  • 사례 연번
    MDA/2015/029
  • 날짜
    2015-08-04
  • 사례 출판 날짜
    2015-08-04
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/all-accu-chek-insight-insulin-pumps-risk-of-hyperglycaemia-from-rapid-pump-battery-depletion-or-unexpected-shut-down
  • 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
    Roche has identified that the use of low-quality batteries or users incorrectly confirming the battery type in the pump settings can lead to unexpected rapid power depletion or a shutdown of the pump. If this goes undetected, patients could experience hyperglycaemia due to under delivery of insulin.Roche has provided updated handling instructions and battery model recommendations in their FSN issued in June 2015 (manufacturer’s reference: SB_RDC_2015_04) but has not had enough replies to know that healthcare providers and users have received and acted on this advice.
  • 원인
    (roche diabetes care) advice from manufacturer to users about the correct battery specification and appropriate pump settings (mda/2015/029).
  • 조치
    Identify users of all Accu-Chek® Insight insulin pumps Ensure that all users receive the manufacturer’s field safety notice (FSN), understand the problem, use batteries meeting the specification detailed in the FSN and confirm battery type in the pump settings Ensure systems are in place to supply users of Accu-Chek® Insight insulin pumps with batteries meeting the specification advised by Roche Ensure that all users are aware that if they experience a rapid decrease in power they should contact the Accu-Chek® Pump Care Line on 0800 731 22 91 Complete and return the FSN acknowledgement form to Roche

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