LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

TICKET SEARCHES DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR LIKELY CAUSE LOT 25802UN16. TRACKING AND TRENDING REPORT REVIEW FOR THE ARCHITECT LACTATE DEHYDROGENASE ASSAY DETERMINED THAT THERE ARE NO RELATED ADVERSE OR NON-STATISTICAL TRENDS. A BATCH RECORD REVIEW WAS COMPLETED WHICH INCLUDED REVIEW OF THE CERTIFICATE OF ANALYSIS FOR THE LIKELY CAUSE LOT. THIS REVIEW INDICATED THAT THE LOT PASSED ALL ACCEPTANCE REQUIREMENTS. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. THE CUSTOMER'S INSTRUMENT LOGS WERE REVIEWED. THIS REVIEW FOUND THE BEGINNING OF THE REACTION CURVE FOR THE ELEVATED RESULT WAS TOO HIGH. ADDITIONALLY, MULTIPLE OCCURRENCES OF ASPIRATION ERRORS AND INSTRUMENT HARD STOPS WERE IDENTIFIED. USE ERROR MAY HAVE CONTRIBUTED TO THE CUSTOMER'S ISSUE. ERROR CODES IDENTIFIED DURING THE INSTRUMENT LOG REVIEW INDICATE A POSSIBLE SAMPLE HANDLING ISSUE AND OR DIRTY CUVETTES WHICH MAY CONTRIBUTE TO FALSE ELEVATED RESULTS. A SYSTEMIC ISSUE AND OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

Description of Event or Problem

THE ACCOUNT GENERATED A FALSELY ELEVATED ARCHITECT LACTATE DEHYDROGENASE (LDH) OF 1724.8 U/L ON A PATIENT SAMPLE THAT REPEATED 158.5 AND 155.3 U/L IN (B)(6) 2017. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.