Events

TRUCAL HbA1c Liquid, Presentation: X 0.25 mL - Level 1: 1 X 0.25 mL / Level 2: 1 X 0.25 mL / Level 3: 1 X 0.25 mL / Level 4: 1 X 0.25 mL, Registration No. 10350840198, lots: 19433-19436, 19949-19952 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Biosys Ltda; DiaSys Diagnostic Systems 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
    1494
  • 날짜
    2014-12-26
  • 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
    According to the company's manifestation, since HbA1c is used as a monitoring parameter that takes into account the history of glycemia, a critical impact is not expected in the decision of the therapy, since it will be established taking into consideration other parameters current clinical practice.
  • 원인
    Internal measurements performed by the manufacturer of the product showed that the values ​​obtained with the onhba1c kit (2/3 regent system) calibrated with the cited trucal hba1c batches presented lower values ​​when compared with measurements performed with the hplc comparison system. the manufacturer assumes that the reagent reacts differently when using fresh sample or frozen sample, and the ifcc reference material used for reagent standardization was frozen sample. because of these observations, patient sample values ​​around the endpoints (48mmol / mol as diagnostic cut-off and 53 mmol / mol as therapy target value) are 6-10% lower.
  • 조치
    The manufacturer company DiaSys repatriated the reagent using fresh sample as reference material, which was standardized with the HPLC method calibrated by the IFCC material. The registry holder in Brazil forwarded communication on the new standardization and also directed the laboratories to check the need to check the values ​​of patients previously determined

Device

TRUCAL HbA1c Liquid, Presentation: X 0.25 mL - Level 1: 1 X 0.25 mL / Level 2: 1 X 0.25 mL / Leve...

Manufacturer

Biosys Ltda; DiaSys Diagnostic Systems Gmbh
  • Source
    ANVSANVISA