Events

Accu-Chek Performa Nano 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Roche Diabetes Care 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2016-07-19
  • 사례 출판 날짜
    2016-07-19
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160719.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: roche accu-chek performa nano the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning accu-chek performa nano manufactured by roche diabetes care. the affected lot numbers are 10135127 and 10134053. during internal testing, the manufacturer has detected the code key to be missing in 1,200 accu-chek performa nano kits out of the affected lots. the accu-chek performa nano blood glucose meter cannot be operated without the pre-inserted code key. according to the manufacturer, appropriate corrective measures to the production process have been implemented. new accu-chek performa nano kits will be available shortly. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-11-july-15-july-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 july 2016.

Device

Accu-Chek Performa Nano
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Roche Accu-Chek Performa Nano
  • Manufacturer
    Roche Diabetes Care

Manufacturer

Roche Diabetes Care