Events

Notificaciones De Seguridad De Campo acerca de VITEK® 2 Identification cards

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
    A potential issue was identified related to the white pouch which contains vitek® 2 test cards for the product lots specified in appendix a. biomérieux has determined that the integrity of some of the vitek® 2 test card pouches may be compromised. based on our investigation, a compromised test card pouch can impact card reagents due to the entry of moisture. the white pouch is composed of five (5) layers of material, four (4) of which are clear. all five layers must be compromised for a pouch to potentially allow moisture to enter the pouch. upon visual inspection of the pouch, you may notice a small puncture or tear in the packaging at the "stitch seal" (see figure a immediately below). per product labeling, do not use the card if the pouch (the white protective package cover) is damaged. based on internal testing, approximately 20% of card pouches exhibited a visual defect; the majority of card pouches with this visual defect maintained pouch integrity, i.E. at least one of the five material layers remained intact. however, 1 in 200 (0.5%) card pouches that passed careful visual inspection failed further integrity tests, indicating the potential for entry of moisture. .

Device

VITEK® 2 Identification cards

Manufacturer

bioMérieux