Events

Notificaciones De Seguridad De Campo acerca de ADVIA Centaur®

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por SIEMENS HEALTHCARE DIAGNOSTICS INC..

¿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
    2014-04-25
  • Fecha de publicación del evento
    2014-05-16
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2014/05/16/vazno-obavestenje-o-medicinskim-sredstvima-3/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare diagnostics has shown that fluorescein-containing samples can show interference with advia centaur® systems tsh3 ultra, vitamin d and advia centaur brahms procalcitonin essay. research has shown that patients undergoing angiography with fluorescein can retain a small amount of fluorescein in the body from 48 to 72 hours after the procedure. in patients with renal insufficiency, retention may be significantly longer. samples containing fluorescein may give false-lower values ​​when tested with the advia _ centaur tsh3 ultra essay. on interference with florescein, the tsh3 ultra values ​​obtained may be less than 0.01 miu / l. these falsely reduced values ​​are important for monitoring patients with thyroid cancer because the physician can conclude that adequate suppression of tsh has been achieved. samples should be taken again after eliminating fluorescein to obtain tsh3 ultra results without interference. samples containing fluorescein may give false-lower values ​​when tested with the advia centaur brahms procalcitonin essay. for florescein interference, the values ​​obtained for procalcitonin may be less than <0.02 ng / ml. samples should be taken again after eliminating fluorescein in order to obtain safe results for procalcitonin without interference. samples containing fluorescein may give false elevations when tested with the advia centaur vitamin d essay. with florescein interference, the values ​​obtained for vitamin d may be > 150 ng / ml (> 375 nmol / l). samples should be taken again after eliminating fluorescein in order to obtain safe results for vitamin d without interference. the instructions for use for the advia centaur systems tsh3 ultra, vitamin d and advia centaur brahms procalcitonin tests will be supplemented to include a sentence concerning potential fluorescein interference.

Device

ADVIA Centaur®

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ALIMSA