Events

Trade name: ADVIA Chemistry Triglicerides Concentrate TRIG_c Technical name: PROGESTERONE Registration number ANVISA: 10345160327; 10345161844; 10345160654 Hazard Class: II Affected Model: 50 determinations; 250 determinations; kit for 100 tests; kit for 200 tests; kit for 600 tests. Affected lot / series numbers: 0 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A; 1) Siemens Healthcare Diagnostics Inc. 2) Siemens Healthcare Diagnostics Products Ltd. 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
    2100
  • 날짜
    2017-01-19
  • 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
    These trials should not be used to report results to patients who are using DHEA supplements. For patients using DHEA supplements, an alternative method should be used to measure Progesterone concentrations, such as Liquid Chromatography - Mass Spectroscopy (LCMS), which is not expected to demonstrate cross-reaction with DHEA-S. However, Siemens Progesterone assays can continue to be used to report results from patients not using DHEA supplements.
  • 원인
    Siemens healthcare diagnostics has confirmed that the presence of dhea-s (a dhea metabolite, a steroid hormone that is used as part of in vitro fertilization (ivf) protocols to increase the ovarian response and in treatment results) causes falsely elevated results for the progesterone trials listed in the "product data" annex, close to the clinically important decision level of progesterone.
  • 조치
    Field Action Code CC 17-06 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send letter to the client.

Device

Trade name: ADVIA Chemistry Triglicerides Concentrate TRIG_c Technical name: PROGESTERONE Registr...

Manufacturer

Siemens Healthcare Diagnósticos S.A; 1) Siemens Healthcare Diagnostics Inc. 2) Siemens Healthcare...