Events

Trade Name: AUTOMATIC BLOOD COAGULATION ANALYSIS SYSTEM Technical Name: Coagulation Parameters Determination Device ANVISA Registration Number: 0345161778; 10345161920 Hazard Class: II Affected Model: CS-2100i; CS-5100 Serial numbers affected: All serial numbers. 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 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
    2167
  • 날짜
    2017-02-10
  • 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
    Clients using the INNOVANCE D-Dimer assay on the CS-Series blood coagulation analyzer (CS-2100i, CS-5100) should change the limit of the minimum extrapolation value within the INNOVANCE D-Dimer setting and the calibration must be according to the concentration of the calibrator to the new threshold.
  • 원인
    Siemens healthcare diagnostics has confirmed that in very rare circumstances a false negative result for the innovance d-dimer assay can be reported by cs-series automatic blood clotting analysis systems (cs-2100i, cs-5100) if the initial result is falsely flagged with an antigen excess error that triggers automatic re-reading at 1/19 dilution and the raw rerun signal is less than the method's white limit (lob). under such conditions, re-reading of low values ​​may be strongly affected by the signal noise of the optical system and may generate an erratically low optical gross value. this gross value will be corrected by the dilution factor and can be deduced from the calibration curve in a false low range.
  • 조치
    Field Action Code PH 17-006 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make letter to the client.

Device

Trade Name: AUTOMATIC BLOOD COAGULATION ANALYSIS SYSTEM Technical Name: Coagulation Parameters De...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Products GmbH.