The following link will take you to  letter from the FDA to diabetes device company. It would appear that medical device reports should have been filed when meter failed to report lows. Here is a little quote that makes it clear why we need to StripSafely: Complaints 618, 779, 728, and 818 describe events in which

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Dr. Richard Kahn professor of medicine at the University of North Carolina and  formerly chief scientific and medical officer of the American Diabetes Association wrote a commentary in Roll Call titled: Competitive Bidding Puts Diabetes Patients at Risk. In that piece he says: Many of our most vulnerable citizens will assume the test they use is

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