Events

Alerta De Seguridad para REVISION DATE OF REVISION DIMENSION® Technical Name: REVISED IRRIGATION REAGENT - DIMENSION® ANVISA Registration Number: 10345161043 Hazard Class: II Affected Model: Affected Lot / Series Numbers: BA7006, BA7116, BB7006, DB6267, FD6309 , GB7060

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
    2095
  • Fecha
    2016-09-30
  • 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
    If users receive any complaints of illness or adverse events associated with the product, they should immediately contact the Siemens Customer Support Center or the Siemens technical support representative in their locality.
  • Causa
    Iron dimension and dimension wear a concentration other than that listed in the instructions for use. deferoxamine is cited in the directions for use dimension and dimension vista as a non-interfering substance. the concentration that was used for interference tests (250 ng / dl or 3.8 nmol / l) is significantly lower than expected in clinical practice. siemens healthcare diagnostics sa is providing an update in the section limitations of the instructions for use procedure, iron test for dimension and dimension vista systems, indicating that: patients treated with drugs that bind to metals (eg deferoxamine) may present a reduction in values iron, since the chelating iron may not react adequately in this test. the reference to deferoxamine at a concentration of 250 ng / dl (3.8 nmol / l) will be removed from the section "non-interfering substances" in the instructions for use. the information provided in this release, related to deferoxamine, replaces the information contained on this substance in the current ferro operating instructions for the dimension and dimension vista systems until their respective operating instructions are updated.
  • Acción
    Field Action Code VC 16-07 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

REVISION DATE OF REVISION DIMENSION® Technical Name: REVISED IRRIGATION REAGENT - DIMENSION® ANVI...

Manufacturer

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