Events

Product name: VITEK AST N 239 Card - Colistin (cs01n) Technical Name: VITEK AST Card N 239 ANVISA Registration Number: 10158120592 Hazard Class: II Model Affected: Not Applicable 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 bioMérieux Brasil Ind. Com. de Prod. Lab. ltda.; bioMérieux 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
    2300
  • 날짜
    2017-05-24
  • 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
    For the reasons explained in the brief description of the problem, we recommend to customers (users of the Vitek AST N 239 card): 1- Use an alternative method (which they must decide which to implement, based on the technical literature available in the microbiology area), before colitis, when using the Vitek 2AST N 239 card (cs01n). 2 - Create the BIOART rule in Vitek equipment, to stop the emission of the results for colistin until the supporting test (optional method mentioned above) is completed (Vitek 2 Reference Manual Software Online). 3- Ensure that the guidelines contained in the letter to the clients (attached to this form) will be passed on to all appropriate personnel in their laboratories for their science. 4- Keep the guidance letter filed with the technical documentation of the Vitek 2 equipment. 5- Complete the knowledge form that accompanies the letter to the clients and return the same as soon as possible to the Dept. of Integrated Customer Service for bioMérieux Brasil.
  • 원인
    Eucast and clsi have issued a recommendation that the broth microdilution method is the only method for antibiotic susceptibility testing recommended for the antibiotic colistin. as a result some customers contacted biomérieux with issues related to the vitek 2ast n 239 card (cs01n), as this product was developed by dilution in agar. an investigation was developed to document the performance level of the vitek 2ast n 239 card (cs01n) and to identify any possibility of deviation of this card from its development. the investigative tests included the card in question and broth microdilution and microdilution agar methods; using 290 isolates with varying degrees of colistin sensitivity. two control microorganisms were included in the test (e.Coli atcc 25922 and p.Aeruginosa atcc 27853). the mic results for the 03 methods were purchased and evaluated. the research demonstrated an unacceptable level of false susceptibility with vitek 2ast n 239 (cs01n) when compared to agar dilution (reference method employed in carton development) and broth microdilution (eucast and clsi recommended method) ). in recent years the use of colistin has been greatly increased, giving rise to a change in epidemiology since the development of vitek 2ast n 239 (cs01n). internal investigations concluded that the carton in question for colistin did not perform adequately when compared to broth microdilution and agar dilution methods.
  • 조치
    Field Action Code FSCA 3490 triggered under the responsibility of the company bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda. Company will advise clients on the use of optional methodology for "susceptible" results related to the antibiotic Colistina cs01n, contained in Vitek AST N 239.

Device

Product name: VITEK AST N 239 Card - Colistin (cs01n) Technical Name: VITEK AST Card N 239 ANVISA...

Manufacturer

bioMérieux Brasil Ind. Com. de Prod. Lab. ltda.; bioMérieux Inc.