Events

Avis De Sécurité sur NovoPen Echo

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par NOVO NORDISK.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2017-03-07
  • Date de publication de l'événement
    2017-10-07
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2017/07/10/vazna-bezbednosna-informacija-za-osobe-sa-dijabetesom-koje-koriste-pen-brizgalicu-novopen-echo/
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    EVG2299-3, EVG5699-4
  • Manufacturer
    NOVO NORDISK

Manufacturer

NOVO NORDISK