Events

Accu-Chek Mobile Blood Glucose Monitoring System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Roche Diagnostics Australia Pty Limited 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2014-RN-00438-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-04-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00438-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Roche diabetes care has become aware of a limitation of accu-chek mobile glucose tests, which may lead to erroneously lowered blood glucose readings in patients undergoing ceftriaxone therapy. this antibiotic substance is used to treat a variety of infections such as respiratory infections or lower urinary tract infections and is only administered intravenously or intramuscularly. the interference is due to the effect of this antibiotic on the measuring system of the device. this limitation is not described in the product labelling.
  • 조치
    Roche Diabetes Care is advising users of this issue and update to the device's labelling. Patients with diabetes who are receiving therapy with ceftriaxone could be using the affected blood glucose monitoring (bGM) system. If this is the case then Roche is recommending customers to obtain an alternative bGM system for the duration of this therapy. For more details, please see http://www.tga.gov.au/safety/alerts-device-accu-chek-mobile-140422.htm .

Device

Accu-Chek Mobile Blood Glucose Monitoring System

Manufacturer

Roche Diagnostics Australia Pty Limited