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
    2017-09-20
  • 사례 출판 날짜
    2017-09-20
  • 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-alarm-failure
  • 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
    Due to an electrical issue there is a risk of a vibrator alarm failure and an intermittent audible alarm failure.The alarm failures will be detected during a pump’s self-test, which is prompted by changing the battery or insulin cartridge. If the failures are detected, the E7 error shows on the pump’s display.Users should contact the customer careline as instructed in the user manual if they cannot resolve an E7 error message.
  • 원인
    Manufactured by roche diabetes care – the audible and/or vibration alarms might not function, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump.
  • 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 information detailed in the FSN and follow the advice given by the manufacturer check the display of the insulin pump regularly seek clinical advice if they are concerned and have an alternative insulin therapy available if necessary contact Roche Careline to get a replacement if the pump continues to display the ‘E7’ error message Return the FSN acknowledgment form to Roche as currently the manufacturer has not received sufficient 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