Events

Notificaciones De Seguridad De Campo acerca de Dimension®, Dimension Vista®

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Siemens Healthcare d.o.o..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-04-12
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare diagnostics has confirmed that dimension tni and dimension vista digxn, e2, ferr, prl, tsh operating instructions (ifu) under the non-interfering substances section of the biotin concentration unit are incorrect, indicating a concentration level at which biotin does not constitute interference. in the case of tni, e2, ferr, prl and tsh, biotin represents a significant interference at the indicated concentration. in the case of the dimension vista e2, which is a competitive test, biotin interference shows a positive deviation, while in the other tests (sandwich methods) it shows a negative deviation.

Device

Dimension®, Dimension Vista®
  • Modelo / Serial
    Dimension Troponin I (TNI) RF621 10464525 All lot numbers up to update Operating Instructions (IFU) Dimension Vista Digoxin (DIGXN) K6435 10488927 All lot numbers up to update Operating Instructions (IFU) Dimension Vista Estradiol (E2) K6463 10489099 All lot numbers up to update Operating Instructions (IFU) Dimension Vista Ferritin (FERR) K6440 10445136 All lot numbers up to update Operating Instructions (IFU) Dimension Vista Prolactin (PRL) K6462 10488398
  • Manufacturer
    Siemens Healthcare d.o.o.

Manufacturer

Siemens Healthcare d.o.o.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    AMPMDRS