Events

Alerta De Seguridad para VIDAS D-DIMER EXCLUSION II - Record 10158120656 - Affected lot: 1001399220. UPDATE - 05/14/2013 - This Field Action has been extended to lots 1001408170/1001479890/1001531500/1001632240/1001743890/1001820290 e. 1001860670.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BIOMERIEUX BRASIL S/A.

¿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
    1234
  • Fecha
    2013-03-13
  • 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
    The company states that the cause of the diversion has not yet been identified and that it is investigating. This product is indicated for use in conjunction with a pretest clinical probability assessment model to rule out venous thrombosis and pulmonary embolism in patients suspected of having these conditions. Due to the clinical utility of VIDAS D-DIMER EXCLUSION II, the severity of the hazard of generating a false-negative result is classified as critical. In patients with low or moderate probability for venous thrombosis or pulmonary embolism, false-negative results avoid further diagnostic investigations and, consequently, this may lead to the absence of anticoagulant treatment when it is really necessary. Anvisa follows this Field Action. #### UPDATE - 05/14/2013 - This Field Action has been extended to lots 1001408170/1001479890/1001531500/1001632240/1001743890/1001820290 and 1001860670. The company announces the CLOSURE of this Action by means of file 0381205 / 13-7 and 0603764 / 13-0. ####
  • Causa
    False-negative results below the detection limit (<45ng / ml) in the affected batch.
  • Acción
    BioMérieux recommends that professional users immediately stop using the product, segregate it and send it to destruction. Also, in order to ensure patient safety, perform the retrospective performance of the patients tested with this batch and conduct investigation if the result was <45ng / ml.

Device

VIDAS D-DIMER EXCLUSION II - Record 10158120656 - Affected lot: 1001399220. UPDATE - 05/14/2013 -...

Manufacturer

BIOMERIEUX BRASIL S/A
  • Source
    ANVSANVISA