Events

CHEMICAL SYSTEM VITROS 5,1 FUSION - Codes 6801375/6801890/6801890, Record no. 80145900827, lots: See Annex 1 - Distribution list. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; ORTHO CLINICAL 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
    1675
  • 날짜
    2015-08-27
  • 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 informs that if this anomaly occurs, the VITROS® 5.1 FS System can process samples using the factory default report units that exist in the ADD, instead of the parameters modified by the user (ie SI vs. Conventional units) . The company also informs that it has identified that the root cause of this anomaly is an error in the software code. The resolution is currently under development and will be available in the future version of the software.
  • 원인
    The company received 2 customer complaints about events that occurred during the installation of an add. the following two situations have been reported: 1. when the customer installed the add compatible with the new vitros® chemistry products hba1c reagent kit, the vitros® 5.1 fs system reported the following 2 condition codes (ua7-239 and syd-024 ): the investigation detected that the condition codes occurred because the abbreviated test name of the new vitros® test had the same abbreviated test name as the user defined assay currently in use on its vitros® 5.1 system fs. as a result, the destination of user defined assay has been deleted from the system. 2. when a customer installed the add, the system did not respond (freeze / screen lock), causing the vitros® 5.1 fs system to restart; the system reported a condition code (uz0-047) after the system restarts. - for the 2 software coding error situations, all the default settings were restored from the add, instead of keeping the parameters modified by the user (configured), and the operator was not alerted by the system.
  • 조치
    The company advises that: • Before installing an ADD compatible with a new test, make sure that the new test does not have the same name as another UDA currently on your system. If the names are the same, you will need to: 1. Rename the UDA with a name that is different from the VITROS® short test name 2. Install the ADD. More information in Annex 2 - Communication to customers

Device

CHEMICAL SYSTEM VITROS 5,1 FUSION - Codes 6801375/6801890/6801890, Record no. 80145900827, lots: ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; ORTHO CLINICAL DIAGNOSTICS, INC.