Events

Product trade name: VANC2 ONLINE TDM VANCOMYCIN /// Record number: 10287410652 /// Lots affected: 60199901; 60229601; 60434301; 61143301; 61187701; 61647301; 61651201; 61854401; 61955901; 67419801; 68812701; 69069401; 69428701; 69737001; 13312901./// Hazard class of the product: II. 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
    1923
  • 날짜
    2016-06-29
  • 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
    If in doubt, contact the record holder of the company. #### 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
    The registrant forwarded to anvisa the following description: "roche diagnostics gmbh, the legal manufacturer of the product involved in this notification, has identified that the instructions for use for vancomycin used in the cobas c 311/501/502 and modular analytics p present an incorrect method comparison with the cobas integra® 800 analyzer. it should be noted that although the comparison was made with cobas integra® 800, this comparison is also applicable to cobas integra® 400 ". the reagent in cobas integra is not yet harmonized, results generated with cobas integra can be up to 20% higher than those generated with the cobas c or modular analytics p-module analyzers. the comparison of method presented in the use instruction can lead to the assumption that both methods are comparable and may affect the interpretation of vancomycin test results./// possible consequences of using the product: comparison of methods (cobas integra and cobas / hitachi) presented in the current use instruction may potentially cause error in the interpretation of the vancomycin concentration. the difference between the dosages can be interpreted as a decrease in vancomycin concentration, which may lead to increased dosage. in this case, a medical risk of toxic effects due to increased vancomycin dosage can not be excluded.
  • 조치
    Classification of risk: III /// Classification of the field action: Update, correction or complementation of the instructions for use./// Field action code: SBN_CPS_2016_010 /// Recommendations to users and patients: disregard the comparison of incorrect method in the Vancomycin Current Directions for Use. The corrected use instruction will be available in the third quarter of 2016.

Device

Product trade name: VANC2 ONLINE TDM VANCOMYCIN /// Record number: 10287410652 /// Lots affected:...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.