Events

Sirolimus Flex® - Dimension. ANVISA Registry No. 10345161657. Risk class III. Lot: EB6064. Distributed as follows in Brazil: 17 in São José dos Pinhais-PR; 16 in Rio de Janeiro-RJ; 3 in Campinas-SP; 2 in Recife-PE. 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
    1838
  • 날짜
    2016-03-10
  • 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
  • 원인
    Siemens healthcare comes through letter dc 16-01 to alert its customers in brazil about the siro reagent, lot eb6064 that does not meet the stability of open bottle of 2 days. internal tests showed a bias (bias) ranging from -82% to + 123% in a pool sample with a concentration of sirolimus of 8.7 ng / ml [9.5 mmol / l] when tested on subsequent days after well within two days. shortly after opening, the results are not affected at the beginning of the stability period.
  • 조치
    The field action code 16-01 initiated by Siemens addresses the sending of a Letter to the 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: Siemens recommends discontinuing use and disposing of the Sirolimus reagent stock from lot EB6064. In addition, it is recommended that the laboratory conduct a retrospective analysis of the results of Sirolimus samples generated using the EB6064 reagent batch. However, it is worth noting that the sample collection and handling section contained in the Sirolimus reagent's instructions for sample stability is consulted in order to decide whether these samples can be retested using an alternative batch of reagent.

Device

Sirolimus Flex® - Dimension. ANVISA Registry No. 10345161657. Risk class III. Lot: EB6064. Distri...

Manufacturer

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