Estradiol II and Estradiol III 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Roche Diagnostics GmbH 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
    2016-03-02
  • 사례 출판 날짜
    2016-03-02
  • 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 estradiol ii and estradiol iii medical device manufacturer, roche diagnostics gmbh, has issued a medical device safety alert concerning its estradiol ii and estradiol iii assays [catalogue number: 03000079190 and 06656021190; lot number: all]. according to the manufacturer, if the estradiol status of postmenopausal women under treatment with fulvestrant is tested with elecsys estradiol ii or elecsys estradiol iii assays, an interference leading to falsely increased results of estradiol due to the drug may occur. subsequently the incorrect level of estradiol may lead to misinterpretations of the hormone status and the use of fulvestrant may be altered. in addition, the efficiency of anti-estrogen treatment might be underestimated. a medical risk for postmenopausal women under fulvestrant treatment cannot be excluded. the manufacturer advises users that due to the risk of cross reactivity, this assay should not be used when monitoring estradiol levels in patients being treated with fulvestrant. affected users are advised to notify their clinicians that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. if treatment with fulvestrant has been altered or discontinued as a result of falsely elevated estradiol results, an alternate method such as liquid chromatography mass spectrometry (lc-ms), which is not expected to show cross reactivity to fulvestrant, should be used to measure estradiol concentrations and assess the menopausal status of the patient. 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 2 march 2016.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Roche Diagnostics Estradiol II and Estradiol III
  • Manufacturer

Manufacturer