Dose accuracy and durability of the NovoPen 4 insulin delivery device before and after simulation of 5 years of use and under various stress conditions.

OBJECTIVE

The dose accuracy of the NovoPen 4 (Novo Nordisk A/S, Bagsvaerd, Denmark) insulin delivery device was evaluated before and after simulation of 5 years of use and under conditions of mechanical and temperature stress.

METHODS

To simulate 5 years of use of the NovoPen 4, > or =5475 injections were performed automatically, corresponding to 3 daily injections for 5 years. Accuracy in the delivery of 1-, 30-, and 60-U insulin doses before and after simulation of 5 years of use was assessed over the in-use temperature range (5 degrees C-40 degrees C [41 degrees F-104 degrees F]). The durability and dose accuracy of the NovoPen 4 were also assessed after exposure to extremes of temperature (-40 degrees C and 70 degrees C), high relative humidity (95% RH), and mechanical challenges (freefall from 1.5 m at ambient temperature and from 1 m at 5 degrees C, 40 degrees C, and 95% RH).

RESULTS

The dose accuracy of the NovoPen 4 before and after 5 years of simulated use was within International Organization for Standardization 11608-specified limits for all doses studied. Dose accuracy remained within specifications for all doses after exposure to variations in temperature and humidity, and after freefall.

CONCLUSION

The NovoPen 4 exhibited dose accuracy before and after simulation of 5 years of use, across a wide range of temperature and humidity conditions, and after mechanical challenges.