Flexi-Q DV Auto-injector Case Study - DALI Medical Devices

Study Conclusions• The study results establish that the users can perform all criticaltasks without a pattern of preventable use error after training decay• All of the participants who read and followed the IFU were able touse the injector successfully• A small residual risk remains that certain patients may ignore thetraining and instructions which may result in mis-dosing.This risk is one that cannot be eliminated through design orlabeling changes and is a risk that is residual for almost allinjectable drugs, regardless of delivery system (even in prefilledsystems)• Additional information submission to FDA (Jan’ 2012)July2009Feb’2010Nov’2010May2011July2011Jan’201227