Vancomycin 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Roche Diagnostics 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
    2016-05-31
  • 사례 출판 날짜
    2016-05-31
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 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 diagnostics vancomycin medical device manufacturer, roche diagnostics, has issued a medical device safety alert concerning the following products: 04491050190 online tdm vancomycin 100 tests 05108420190 online tdm vancomycin 200 tests 04642490190 hitachi vancomycin (p) 04642481190 hitachi vancomycin (p) the ifus (instructions for use) for vancomycin on cobas c 311/501/502 and modular analytics p-module state an incorrect method comparison against cobas integra 800. since the cobas integra reagent is not yet adapted, results generated with cobas integra are still up to 20 % higher than with cobas c or modular analytics p-module. the method comparison shown may lead to the assumption that both methods are comparable and may affect the interpretation of vancomycin test results. the issue can potentially lead to misinterpretation of results. in case that the first result has been generated with integra and the following result using cobas/hitachi assay, the difference between assays might be interpreted as decrease in vancomycin concentration which can further trigger the increase in the dosage. in this case, a medical risk of toxic effects due to the increased vancomycin dosage cannot be excluded. incorrect method comparison will be deleted from the ifus. affected users are instructed to ignore the wrong method comparison in the ifus. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 may 2016.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Roche Diagnostics Vancomycin
  • Manufacturer

Manufacturer