Risk management personnel tell you that each person who has an adverse event may sue your company which, on average, will cost the company $ 2,000,000 for each adverse event (some people never sue, some get settled for less than this amount, some get tried by to jury and result in a larger judgment, but this is a reasonable average). Calculate how much money your company will likely lose in these cases each year. Compare that to the amount of money you will likely make in revenue (number of test strips you will likely sell each year times cost of a test strip, ~ $ 1 per test strip). Write a brief (<1 page) essay discussing the ethics. 
The device is a glucose meter!