Events

Alerta De Seguridad para RAPIDPoint 500 SYSTEM, Hazard Class I, Registration: 10345161877, Serial numbers: 33897; 34218; 34225; 34227; 34497; 34502; 34515; 34516; 34607; 34608; 34611; 34974; 34975; 34977; 34982; 34986; 34990; 35096; 35097; 35098; 35664; 35666; 35667; 35669; 35671; 35672; 35680; 35724; 35726; 35728; 35729; 35979; 36044./////. RAPIDLab 1200 SYSTEMS, Model: RAPIDLab 1265, Registration: 10345160455, Serial numbers: SEE ANNEX.

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.; 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
    1518
  • Fecha
    2015-01-29
  • 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 data from the manufacturer the health risk related to this issue is limited to the delay in the detection of hyperbilirubenia, while the result is confirmed by biochemical tests if the value found is lower than expected. If you get a result that is greater than expected, phototherapy would already be started and any change in therapy would require confirmation by laboratory biochemical tests.
  • Causa
    Siemens healthcare diagnostics reported a change in the measurement of the neonatal bilirubin parameter (nbili), which may have a variable increase when the concentration of nbili is> 12mg / dl (205 μmol / l) and the thb concentration exceeds the reportable range greater than 25 g / dl (15.5 mmol / l). when this occurs, the analyzer may report results of nbili greater or less than expected.
  • Acción
    Siemens advises customers to perform the procedures described below, and to wait for the company to be scheduled for correction and to file the letter with the laboratory files: • If your analyzer reports "----- ↑" in the result of tHb, and the nBili result is reported, do not release the nBili result reported by the analyzer. • Please review the letter with the Clinical Director of your Laboratory. • Fill in and return the Effective Verification Form attached to the letter to the customer within 7 days. /// (SEE LETTER TO THE CUSTOMER IN ANNEX)

Device

RAPIDPoint 500 SYSTEM, Hazard Class I, Registration: 10345161877, Serial numbers: 33897; 34218; 3...

Manufacturer

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