Events

Field Safety Notices about NovoPen Echo

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by NOVO NORDISK.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-03-07
  • Event Date Posted
    2017-10-07
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2017/07/10/vazna-bezbednosna-informacija-za-osobe-sa-dijabetesom-koje-koriste-pen-brizgalicu-novopen-echo/
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    EVG2299-3, EVG5699-4
  • Manufacturer
    NOVO NORDISK

Manufacturer

NOVO NORDISK