A Warning Letter – non filed MDRs. Why We Need to StripSafely.

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 patients exhibited symptoms of low blood sugar levels after receiving normal (70-110 mg/dL) blood glucose reading results when using your firm’s device. For each of the complaints, emergency technicians confirmed that the patient had low levels (<40mg/dL) of blood glucose. As a result of the low blood glucose levels, the patients required medical intervention (i.e. glucose liquid gels, (b)(4), sugar, IV glucose, juice, glucose water, and jelly sandwich) to preclude permanent impairment of a body function or permanent damage to a body structure. An MDR should have been submitted for each complaint.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm360148.htm

Thanks FDA! Keep it up. More inspection please.