Events

Gentamicin (Gentamicin) Technical Name: GENT2 ONLINE TDM GENTAMICIN ANVISA Registration Number: 10287410655 Hazard Class: II Affected Model: GENT2 Serial Numbers Affected: 11916601 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
    2158
  • 날짜
    2017-02-10
  • 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
    ONLINE TDM Gentamicin (GENT2) As a precautionary measure, you should stop using the ONLINE TDM Gentamicin reagent until further guidance. Any ONLINE TDM Gentamicin kits in your stock may be retained until further notice. For the time being, there is no need to dispose of products that are still expired. Roche Diagnostica is working to provide a solution as quickly as possible, allowing customers to continue to use the Roche ONLINE TDM Gentamicin assay with the Preciset TDM I Calibrator. Roche Diagnostica Brazil will inform you accordingly. Preciset TDM I (Calibrator) The Preciset TDM I calibrator can be used for all other TDM tests on cobas ce MODULAR ANALYTICS

    (except for GENT2) and also for all TDM assays (including GENTM) in COBAS INTEGRA. For the moment, there is no need to eliminate products that are still expired. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.

  • 원인
    Roche diagnostics gmbh, the legal manufacturer of the product involved in this notification, after internal investigations, has identified an increase in patient specimen recovery of approximately 15-20% when using the online tdm gentamicin test with the recent batches of the preciset tdm calibrator i 615118, 619681, 126387, 140735. tdm controls and external quality assessment also showed a recovery recovery of approximately 15%. except for combination with tdm control series lot 125783, in which this effect was not presented. these observations were confirmed for the online tdm gentamicin reagent kits for use in cobas ce analyzers modular analytics

    .

  • 조치
    Field Action Code SBN_CPS_2016_009 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

Gentamicin (Gentamicin) Technical Name: GENT2 ONLINE TDM GENTAMICIN ANVISA Registration Number: 1...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH