Events

Notificaciones De Seguridad De Campo acerca de VITEK® 2 Compact 15 or VITEK® 2 Compact 30 system

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 bioMérieux.

¿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
  • 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
    Customers have reported that some vitek® 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. the issue was reported to occur on vitek® 2 compact 15 and compact 30 systems following a system software update to version 8.01. internal investigation has demonstrated when a card is ejected from a slot number greater that 15/30, respectively, the ejection packet fails to be accepted by the computer, and the card status remains at "preliminary". when the anomaly occurs, data for current and future cards will not be transferred to the computer. the data for the ejected card will be lost. .

Device

VITEK® 2 Compact 15 or VITEK® 2 Compact 30 system

Manufacturer

bioMérieux