Alerta De Seguridad para ADVIA 1200 Chemistry System - Registration No. 10345160456; ADVIA 1650 Chemistry System - Registration No. 10345160453; ADVIA 1800 CHEMISTRY SYSTEM - Registration No. 10345160636; ADVIA 2400 Chemistry System - Registration No. 10345160471. Numbers of series involved - check list attached to this alert.

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 Ltda..

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 individual tests that make up the most common calculations (eg, Anion GAP, A / G ratio, osmolarity, and estimation of ionized calcium) have clinical utility and are generally reported and revised in conjunction with the calculation result. However, the% HbA1C_3 method may be configured to report only the calculated result. In this case, the calculation will not present the flag and can be reported inadequately, without the proper evaluation of the user, which may lead to an undue evaluation of the glycemic control of the patients. The% HbA1c method is a result calculated from the results of tests A1c and tHb. If a flag is associated with the A1 or tHb test, the calculation of the% HbA1c result will not display the flag if the% HbA1c result is within the defined limits. The result% HbA1c calculation is essential among all calculations, since it alone, and not the individual tHB or A1c tests, has clinical utility to the end user. Only the% HbA1c calculation result is evaluated by the operator. Individual test results from all other common test calculations, such as Anion GAP, A / G ratio, osmolarity, and ionized calcium estimation, have clinical value alone and are evaluated by the operator. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Causa
    Siemens has confirmed that the advia 1200, 1650, 1800 and 2400 chemistry systems report results calculated using ratio parameters without error flags when individual test underlying results are used as part of the calculation are flagged. in cases where the error flag suppresses a numeric result, a ratio calculation will not be performed. if a numerical result is generated with a signaling, the ratio calculation will be reported without signaling.
  • Acción
    Siemens recommends its users to: - Identify tests that use parameters calculated on your system and its individual components, these tests should be reviewed before approving the results of the Ratio Parameters test; - Review and evaluate the Flags / Markers associated with individual tests before reporting the calculated test results from Ratio Parameters and; - Review the contents of this letter with the Laboratory Manager and keep the letter in your laboratory records. Please check customer letter (attached to alert)


  • Empresa matriz del fabricante (2017)
  • Source