Accuracy and precision of the NovoPen 3 insulin delivery device after mechanical and temperature stresses.

Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
Olga M SantiagoCarsten Mølgård Kristensen

Abstract

To evaluate the precision, accuracy, and durability of an insulin pen injection device (NovoPen 3) at three preset doses (2 IU, 35 IU, and 70 IU) after exposure to various stress and durability tests that were intended to simulate daily use by patients. Twenty-nine reusable NovoPen 3 insulin delivery devices were tested. The precision and accuracy of 10 insulin pen devices were evaluated after they were subjected to multiple thermal and vibration stress tests. Another 10 pen devices were subjected to a free-fall test. Nine other insulin pens were subjected to endurance testing that simulated 5 years of injections. The accuracy (as measured by the relative error of the delivered dose of insulin) of the insulin pen injection devices was within 1% of the preset dose after all stress or endurance tests. A free-fall test produced no indication of damage except for broken clips and snap catches on the caps, which did not affect the integrity or performance of the insulin pens. The precision of the pen devices (as measured by relative standard deviations of delivered volumes of insulin) was likewise high after thermal stress, vibration stress, free-fall testing, or 5-year endurance testing. Overall, this study showed that the insulin ...Continue Reading

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Citations

Aug 21, 2007·Diabetes Technology & Therapeutics·Jonas KildegaardOle K Hejlesen
Aug 22, 2008·Diabetes Technology & Therapeutics·Sherwyn Schwartz, Aleksandra Vlajnic
Feb 16, 2010·Diabetes Technology & Therapeutics·Umashankar LakshmanadossKrishnakumar Rajamani
Dec 14, 2006·Clinical Drug Investigation·Jørn RexSimon A Lawton
Aug 21, 2009·Journal of the American Pharmacists Association : JAPhA·Lisa Kroon
Oct 27, 2011·Journal of Diabetes Science and Technology·Bärbel Sommavilla, Giacomo Pietranera
Mar 12, 2008·Expert Review of Medical Devices·Samita GargSatish Garg

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