Events

Notificaciones De Seguridad De Campo acerca de NovoPen Echo

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 NOVO NORDISK.

¿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
    2017-03-07
  • Fecha de publicación del evento
    2017-10-07
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2017/07/10/vazna-bezbednosna-informacija-za-osobe-sa-dijabetesom-koje-koriste-pen-brizgalicu-novopen-echo/
  • 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
    Damage (cracking or breakage) can occur if the pen injector carrier comes in contact with certain chemicals, because plastic materials used to produce deviated batches may be weakened by exposure to certain chemicals, for example, when cleaning agents are used. however, if the pen syringe is cleaned as described in the package leaflet, there is no reason to worry and it is unlikely that the cartridge carrier will crack. when using a pen syringe with a cracked / broken cartridge carrier, it may be that the pen emits less insulin than expected, which can be manifested by high blood sugar levels. the risk of developing high blood sugar when using a pen syringe containing the cartridge carrier to which this deviation relates is found to be less than 0.1%, i.E. only 1 in 1000 patients using a pen with a damaged cartridge carrier would experience high blood sugar.

Device

NovoPen Echo
  • Modelo / Serial
    EVG2299-3, EVG5699-4
  • Manufacturer
    NOVO NORDISK

Manufacturer

NOVO NORDISK