Prodigy responds to FDA warning
CHARLOTTE, N.C. – Prodigy Diabetes Care has conducted a regulatory assessment by an independent auditor to examine, review and revise certain procedures and training to ensure compliance with FDA requirements, it told patients, caregivers and partners in a Sept. 4 letter.
“Prodigy assures you that this attention to improvement is an ongoing effort to ensure full compliance,” stated CEO Richard Admani in the letter.
In a Feb. 22 letter, the FDA warned Prodigy about numerous violations, including the company’s failure to notify the agency within 30 days of receiving complaints that its devices may have caused or contributed to a death or injury.
Admani states in the letter that, since February, Prodigy has reviewed all complaints received during 2011-13 and filed medical device reports or MDRs. Additionally, he pointed out that the complaints stem from the occasional “out-of-normal” readings some patients experience from blood glucose monitors and that are not uncommon.
“Whether the cause be contaminated strips due to temperature, batteries, improper storage or handling of strips, or otherwise, all manufacturers receive reports that their devices ‘may have been a factor’ in an injury,” he states in the letter.
The FDA also warned Prodigy about its inspection of goods prior to release to customers. Admani stated in the letter that all test strips sent to patients meet FDA standards, and that in the wake of the warning, Prodigy has conducted additional testing of the lots in question and found all products were in line with federal standards.
“Prodigy’s goal is to provide accurate and reliable products at a good value,” he stated. “Just as important to us as the FDA’s input is feedback from persons who use our products day after day. We welcome your input and will work hard to address your concerns.”