FDA WARNING_LETTER - Prodigy Diabetes Care, LLC - April 16, 2012

An FDA inspection of Prodigy Diabetes Care, LLC (March 5 - April 16, 2012) found their blood glucose monitoring devices (Prodigy Blood Glucose Test System, Prodigy Voice, Prodigy Autocode, Prodigy Pocket) to be misbranded and adulterated.

**Misbranding Violations (21 CFR Part 803 - MDR Regulation):** 1. **Failure to report serious injuries/deaths (21 CFR 803.50(a)(1)):** The firm failed to submit Medical Device Reports (MDRs) within 30 days for complaints (e.g., 618, 779, 728, 818, 598) where patients experienced severe hypoglycemia due to inaccurate device readings, requiring medical intervention. The firm's claim of "user error" was deemed inadequate, as "caused or contributed" includes user error. 2. **Inadequate MDR procedures (21 CFR 803.17):** The "Medical Device Reporting Standard Operating Procedure" (SOP-QA-0021, Rev 2) lacked definitions for reportable events (e.g., "caused or contributed," "serious injury"), instructions for complete event investigations, and details on submitting initial/supplemental/follow-up reports, including specifying "calendar" days and the correct submission address.

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