Abstract
BACKGROUND: The HumaPen Luxura HD insulin pen (Eli Lilly and Company, Indianapolis, IN) was originally designed to deliver accurate doses in half-unit increments from 1 to 30 units. Laboratory testing examined the accuracy of the initial 0.5-unit dose within a 95/95% tolerance interval with respect to a specification of +/-0.5 unit (+/-0.005 ml). METHODS: After priming, operators recorded the first 0.5 unit. Data were analyzed using k-value targets. RESULTS: While examining 577 half-unit doses per device lot, test temperature, operator, or test liquid, at least 95% of the doses were accurate with 95% confidence. All data points were within +/-0.5 unit (+/-0.005 ml). CONCLUSIONS: Dose accuracy of the initial half-unit is achieved with the HumaPen Luxura HD insulin pen.