Events

Alerta De Seguridad para Sirolimus Flex® - Dimension. ANVISA Registry No. 10345161657. Risk class III. Lot: EB6064. Distributed as follows in Brazil: 17 in São José dos Pinhais-PR; 16 in Rio de Janeiro-RJ; 3 in Campinas-SP; 2 in Recife-PE.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc..

¿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
    1838
  • Fecha
    2016-03-10
  • 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
  • Causa
    Siemens healthcare comes through letter dc 16-01 to alert its customers in brazil about the siro reagent, lot eb6064 that does not meet the stability of open bottle of 2 days. internal tests showed a bias (bias) ranging from -82% to + 123% in a pool sample with a concentration of sirolimus of 8.7 ng / ml [9.5 mmol / l] when tested on subsequent days after well within two days. shortly after opening, the results are not affected at the beginning of the stability period.
  • Acción
    The field action code 16-01 initiated by Siemens addresses the sending of a Letter to the Customer with risk classification III (situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences) . Recommendation to Users and Patients: Siemens recommends discontinuing use and disposing of the Sirolimus reagent stock from lot EB6064. In addition, it is recommended that the laboratory conduct a retrospective analysis of the results of Sirolimus samples generated using the EB6064 reagent batch. However, it is worth noting that the sample collection and handling section contained in the Sirolimus reagent's instructions for sample stability is consulted in order to decide whether these samples can be retested using an alternative batch of reagent.

Device

Sirolimus Flex® - Dimension. ANVISA Registry No. 10345161657. Risk class III. Lot: EB6064. Distri...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA