NovoPen Echo 에 대한 현장 안전성 서한

Field Safety Notice

2017-03-07

2017-10-07

Serbia

ALIMSA

https://www.alims.gov.rs/latin/2017/07/10/vazna-bezbednosna-informacija-za-osobe-sa-dijabetesom-koje-koriste-pen-brizgalicu-novopen-echo/

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.