Events

Trade Names: Advia 1650 Chemistry System, registration 10345160453; Advia 1200 Chemistry System, registration 10345160456; Advia 2400 Chemistry System, registration 10345160471; Advia 1800 Chemistry System, registration 10345160636; Clinical Chemistry System Dimension, registry 10345161629; Clinical Chemistry System Dimension Rxl Max, registration 10345161632; Clinical Chemistry Analyzer System Dimension, registry 10345161633; Dimension EXL system, registration 10345161695; Dimension EXL 200, registration 10345161762; ADVI Chemistry XPT, registration 10345161947. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc. 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
    1876
  • 날짜
    2016-04-18
  • 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
    Recommendations to Users and Patients: Siemens recommends venipuncture should be performed prior to the administration of NAC or Metamizol. Baseline values ​​prior to administration of NAC or Metamizole therapy are not affected.
  • 원인
    Siemens healthcare is alerting its customers in brazil about interferences of n-acetylcysteine ​​(nac) and metamizol and in the use of the above products, that is, in tests that use trinder reactions or principles of trinder reactions. the trinder reaction is a reaction where hydrogen peroxide formation occurs, and subsequently reacts with a derivative of phenol and aminoantipyrine, which in the presence of peroxidase, forms a colored quinone product. siemens has confirmed that falsely diminished results may occur in samples collected from patients receiving n-acetylcysteine ​​(nac) or metamizole. nac is the accepted antidote for acetaminophen toxicity and is warranted in patients at significant risk of hepatotoxicity. metamizole is an anti-inflammatory and antipyretic drug that is banned in most countries because of the potential for nephrotoxicity.
  • 조치
    The action of field code CHC 16-01 & DC 16-02 initiated by Siemens addresses the sending of a Letter to Customer with risk classification III (situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences). Recommendation to users and patients: Venous puncture should be performed prior to the administration of NAC or Metamizole. Baseline values ​​prior to administration of NAC or Metamizole therapy are not affected.

Device

Trade Names: Advia 1650 Chemistry System, registration 10345160453; Advia 1200 Chemistry System, ...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc.