Events

Alerta De Seguridad para 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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biosys Ltda; DiaSys Diagnostic Systems Gmbh.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1494
  • Fecha
    2014-12-26
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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.
  • Acción
    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