LACTATE DEHYDROGENASE (LDH)

Additional Manufacturer Narrative

(B)(6). THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER DUE TO PRIVACY ISSUES. A REVIEW OF TICKETS DETERMINED THAT THERE IS NOT AN INCREASE IN COMPLAINT ACTIVITY FOR LDH REAGENT LOT 02747UN20. TRENDING REVIEW DETERMINED NO TRENDS FOR FALSELY ELEVATED RESULTS FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. FILE SAMPLE TESTING WAS NOT PERFORMED AS THE ORIGINAL SAMPLE GENERATED CORRECT RESULTS UPON RETESTING. QUALITY CONTROL HAS BEEN IN RANGE AT THE TIME OF THE INCIDENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE LACTATE DEHYDROGENASE (LDH) REAGENT, LOT NUMBER 02747UN20, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 (B)(6) INITIAL = 1563.0U/L (NORMAL RANGE 125-220U/L) / RETEST = 147 AND 148U/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.