Events

Product name: Elecsys Estradiol II assay (Registration number: 10287410228) and Elecsys Estradiol III assay (Registration number: 10287411088) /// Product code: 3000079190 and 6656021190./// Product hazard class: Class II. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Roche Diagnóstica Brasil Ltda.; 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
  • 사례 ID
    1844
  • 날짜
    2016-04-01
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    The possible consequences of using the product are described as follows by the company: "If the level of estradiol of postmenopausal women under treatment with fulvestrant is dosed with the Elecsys Estradiol II or III trials, falsely increased estradiol results may occur due to In addition, the efficacy of anti-estrogen drug treatment may be underestimated, and the use of fulvestrant may be underestimated, there are no known cases where this issue caused any serious adverse events. " #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • 원인
    The company describes that "roche diagnostics gmbh, the legal manufacturer of the product involved in this notification, after an" urgent field safety notification "recently issued by siemens healthcare diagnostics stating that the drug fulvestrant may cause falsely elevated results in the estradiol tests performed by them (e2), has identified the need to also test its estradiol assays for this cross-reactivity / cross reactivity (xr) with the drug fulvestrant. ".
  • 조치
    Field action code: SBN_CPS_2016_005./// The company guides its users to its users and patients who: 1. Due to the risk of cross-reaction, these trials (Estradiol II and III) should not be used for the therapeutic monitoring of levels of estradiol in patients being treated with the drug fulvestranto /// 2. Notify their physicians that the use of fulvestrant may increase the apparent concentration of estradiol in women receiving this drug. If fulvestrant treatment has been altered or disrupted as a result of falsely elevated estradiol results, an alternative method such as LC-MS (Mass Spectrometer Liquid Chromatography), which is not expected to cross-reactivity with fulvestrant, should be used to measure estradiol concentrations and to assess the patient's menopausal status.///3. Fill out and sign the form on the last page of the notification sent and send it to Roche Diagnóstica Brasil./// 4. Roche Diagnostics GmbH will also update the instructions for use of the Elecsys Estradiol II and Estradiol III tests to alert you to such interference.

Device

Product name: Elecsys Estradiol II assay (Registration number: 10287410228) and Elecsys Estradiol...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.