Events

E-test Ertapenem E-test Ertapenem Registration number ANVISA: 10158120623 Hazard class: II Affected model: Not applicable Affected serial numbers: 1003523980/1003528910/1003528910/1004345590/100455930/1004624930/1004872750/1004886970 / 1005177360/1005208910/1005183510 and 1005353450 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 bioMérieux Brasil Indústria e Comércio de Produtos Laboratorias 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
    2277
  • 날짜
    2017-04-25
  • 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- To the Medical Officer: Share this information with the right people in your lab, save a copy in your files, and pass it on to all sectors that may be using the product, including the units to which you may have sent units of those lots . 2- Users of CLSI and EUCAST 2017 clinical guidelines may continue to use the Ertapenem E-test blister pack (Ref. 531600), except for the Streptococci group, including S. pneumoniae strains. 3- Among the tests performed previously, we ask you to identify possible false positive results, analyze the related risks and determine the appropriate actions, if revelevangtes. 4- Contact bioMérieux for product compensation if necessary. 5- Return the Confirmation of receipt of the guidance letter (Annex A of the letter) to confirm receipt of the notification. ### Update of the field action: UPDATED ON 10/25/2017, the company presented the report of completion of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • 원인
    Based on the epidemiological evolution of peaks and detection of some resistant strains of strptococcus from clinical specimens (about 1 to 5% according to the crsi crocheting points), which did not exist at the time of registration of the e-test product ertapenem and also in the impact change study, biomérieux initiated an internal study with 234 peaks including enterobacteriaceae, haemophillus, s.Penumoniae, s.Viridans, streptococcus beta-hemolytic and anaerobic peas. the results confirmed a potential performance problem in the categorization of strains for the s. viridans and s.Pneumoniae groups based on the clsi and eucast 2017 cutoff points, which could lead to false susceptibility instead of e-test resistant results ertapenem, when purchased with the micro dilution in broth (mdc) reference method. this problem was not evaluated at the time of product registration because at that time it was very rare or nonexistent resistant to this drug.
  • 조치
    Field Action Code FSCA 3329 triggered under the responsibility of the company bioMérieux Brasil Indústria e Comércio de Produtos Laboratorias Ltda. Company will send letter to customers.

Device

E-test Ertapenem E-test Ertapenem Registration number ANVISA: 10158120623 Hazard class: II Affect...

Manufacturer

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