Events

Trade name: GENT2 ONLINE TDM GENTAMICIN (Products for in vitro diagnostic use) /// register 10287410655 /// risk class II (Products presenting medium risk to user or patient and low risk to public health) // Lot 11916601 (distributed 2 in São Paulo-SP and 1 in Porto Velho-RO). 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
    1909
  • 날짜
    2016-06-13
  • 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 questions and support, please contact the CEAC Service Center - 08007720295 of Roche Diagnóstica Brasil Ltda. #### 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

    . faced with this question, a possible achievement of falsely elevated gentamicin levels may lead to incorrect reduction of drug dosage. too much dosage reduction may result, given the worst case scenario, in subtherapeutic levels of gentamicin. gentamicin is also used for the treatment of contagious infections, therefore, very low serum levels of this drug may also lead to the spread of the infection.

  • 조치
    Action code SBN_CPS_2016_009. Letter to customers with recommendations to Stop using GENT2 temporarily until a valid Reagent / Calibrator / Control combination is available.

Device

Trade name: GENT2 ONLINE TDM GENTAMICIN (Products for in vitro diagnostic use) /// register 10287...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH