FDA warns Prodigy
By HME News Staff
Updated Tue September 3, 2013
CHARLOTTE, N.C. - Add Prodigy Diabetes Care to the list of HME manufacturers that has received warning letters from the U.S. Food and Drug Administration (FDA).
In a letter dated Feb. 22 but only posted to the agency's website July 11, the FDA faults Prodigy with, among other things, “failure to report to the FDA no later than 30 days after the day that your firm received or otherwise became aware of information that a device that it markets may have caused or contributed to a death or serious injury.”
The FDA also faults Prodigy with “failure to adequately develop, maintain and implement medical device reporting (MDR) procedures.”
The letter includes examples of complaints with Prodigy's glucose meters, including “complaints (that) describe events in which patients exhibited symptoms of low blood sugar levels after receiving normal blood glucose reading results when using your firm's device.”
The FDA has asked Prodigy to send notification of the specific steps it has taken to correct the noted violations, including an explanation of how it plans to prevent these violations, or similar ones, from occurring again.
The FDA inspected Prodigy from March 5 to April 16, 2012, and issued a Form 483 to the company's director of regulatory affairs. Prodigy responded May 4, 2012, but the FDA found its response “inadequate.”
Invacare, Merits Health and GF Health Products have all come under scrutiny by the FDA recently.
Go here to read the FDA's letter to Prodigy:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm360148.htm#.UhYvg45gcaE.email
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