Events

Vitek MS V2.0 and Vitek MS V 3.0 - Clinical: Vitek MS V2.0 and Vitek MS V 3.0 - Clinical 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux S.A. 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
    2217
  • 날짜
    2017-03-02
  • 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
    1- Distribute the letter to the client for all technical staff in the laboratory. Keep a copy in your files. 2- Distribute the information to all areas that can make use of the VITEK MS system, including others to which the VITEK MS system may have been transferred. 3- When evaluating the identification results obtained from VITEK MS take the limitation reported. 4- Complete the return form to bioMérieux and send us. #### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and destination of the nonconforming products.
  • 원인
    As described in the equipment use manual (chapter 2, "results and interpretation", table 2), the vitek ms system can provide 03 types of identification results for the samples, depending on the confidence interval obtained. the myla software displays the results indicating the level of confidentiality. to consolidate the results, the identification of each sample is presented in a graphic and colored way: green square = good identification (means good confidence level and the system displays 01 identification as result); yellow triangle = low identification (means, low discrimination in the result.) the user will have several identification options as a result, so the user must do additional tests to obtain the final result of the identification); red circle = no identification (the system will show "no result" or "more than 04 identification results." the user must perform additional tests to obtain the result of the identification). a limitation of the vitek ms system has been identified: it may provide an incorrect identification result if the tested species are not included in the vitek ms equipment database. this is a system limitation for the entire maldi-tof database, which is not currently described in the system documentation. the vitek ms system is a system of identification of microorganisms that works based on a classification pattern of the species. the limitation verified in the system is due to the use of predictive modeling based on supervised learning. typically these types of models include an algorithm that learns certain properties of a set of data spectra (eg presence of peaks) to make these predictions. when the micro-organism tested is not part of the.
  • 조치
    Field Action Code FSCA 3305 triggered under the responsibility of the company bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda. Company will send letter to customers.

Device

Vitek MS V2.0 and Vitek MS V 3.0 - Clinical: Vitek MS V2.0 and Vitek MS V 3.0 - Clinical

Manufacturer

bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux S.A.