Events

Notificaciones De Seguridad De Campo acerca de Fluorocell PLT

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 Sysmex Europe GmbH.

¿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
    2017-08-28
  • 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
    Due to the low plt f results from the above affected fluorocell plt f lots, sysmex europe gmbh has decided, as part of the preventive measure, to withdraw the mentioned reagents.   the individual cartridges of the above-mentioned reagent lots indicate a sinusoidal difference between platelet counts of plt i and plt f. the results of plt f are much lower than the results of plt i. in some cases, the warning "abnormal plt scattergram" was triggered. however, this warning is not triggered in all cases. too low plt f was associated with a false estimate of the platelet population in the plt-f irradiation diagram.   internal testing with fresh human blood samples showed a decrease in lateral fluorescence (sfl) for samples measured in the plt f channel, in cases where the affected fluorocell reagent lot was used plt. as a result, the plt f population was not adequately counted as plt, so plt f scores became false. this can be seen in the dark blue-colored proportion of the plt population (see figure 2). additionally, ipf diagnostic parameters (ipf%) and ipf # (ipf counting) were potentially affected.

Device

Fluorocell PLT

Manufacturer

Sysmex Europe GmbH