Events

Product 1. BCS SYSTEM, registration 10345161639, risk class I, batches affected: 321208; 361922; 251626; 290672W; 161762. /// Product 2. BCS XP SYSTEM, registry 10345161642, risk class I, batches affected: 311502; 280727; 280800; 301266; 301267; 280775; 221651; 331848; 442036. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products 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
    1595
  • 날짜
    2015-05-21
  • 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
    According to the manufacturer the health risk is related to the possibility of inappropriate classification, for higher values, of Factor IX, for results of patients in the lower reading range. It is important to know that hemophilia B is characterized by the deficiency of Factor IX coagulation activity that results in prolongation of bleeding after injury, dental extractions or surgeries, and recurrent delay or bleeding before complete wound healing.
  • 원인
    Release of erroneously high results for factor ix with the application protocols of the bcs and bcs xp systems at the lower limit of the measurement range.
  • 조치
    The registry holder will change protocols for the implementation of the Factor IX Define test. In addition, it is advised to discontinue use of the "Factor IX with Pathromtin SL [34]" application protocol and instead use the "Factor IX with Pathromtin SL [463]" application protocol; discontinue the use of extrapolation for reading values ​​at lower levels of the "Factor IX with Pathromtin SL [463]" application protocol and "Factor IX with Actin [467]" application protocol. Do not report patient results below 30% F IX for application protocols "Factor IX with Actin FSL [471]".

Device

Product 1. BCS SYSTEM, registration 10345161639, risk class I, batches affected: 321208; 361922; ...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products GmbH