Events

Cobas b 123 Fluid Pack 200 and Cobas b 123 Fluid Pack 400, Registration No. 10287410927; Cobas b 123 Fluid Pack COOX 200, Cobas b 123 Fluid Pack COOX 400 and Cobas b 123 Fluid Pack COOX 700, Registration No. 10287410931. Lots involved Annex 1 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Roche Diagnóstica Brasil Ltda.; Roche Diagnostics 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
    1654
  • 날짜
    2015-07-20
  • 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
    The company clarifies how the QC results may be low average values, but still within 2 standard deviations (SD), there is a potential risk of erroneously generating low PO2 results in patient samples, especially in blood samples, in values ​​below 50 mmHg of PO2. The company further reports that to date, there are no known cases where this issue caused any serious adverse events for patients.
  • 원인
    Roche diagnostics gmbh, a legal manufacturer of the products involved in this notification, after complaints and internal investigations, has identified changes in qc (values ​​of cq below target values) of the po2 parameter in the cobas b 123 poc systems caused by a calibration problem with the parameter po2 in specific batches of cobas b 123 fluid pack (200 and 400 tests) and cobas b 123 fluid pack coox (200, 400 and 700 tests).
  • 조치
    Actions to be taken by the customer / user The company recommends that: - For the affected batches of cobas b 123 Fluid Pack listed in Table 1 currently in use, the PO2 parameter must be deactivated in the equipment. Requests that the detailed workaround presented in Appendix 1 to the Customer Letter (Annex 2) be followed. - Cobas b 123 Fluid Packs from affected batches not yet in use can be disposed of on site. - Replacement of affected lots may be requested from Roche Diagnóstica Brasil Ltda. The company notes that not all drives have this error, but for security reasons, requests that they not use the affected batches listed with the PO2 parameter enabled. Distribution map - Annex 3

Device

Cobas b 123 Fluid Pack 200 and Cobas b 123 Fluid Pack 400, Registration No. 10287410927; Cobas b ...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH