LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, REVIEW OF COMPLAINT ACTIVITY, REVIEW OF MANUFACTURING DOCUMENTATION AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE CUSTOMER INDICATED INSPECTION OF THE SAMPLE SHOWED SMALL SUSPENDED PARTICLES. REVIEW OF COMPLAINT ACTIVITY ASSOCIATED WITH REAGENT LOT 33529UN19 IDENTIFIED ONE OTHER RELATED COMPLAINT. REVIEW OF TRACKING AND TRENDING REPORTS ASSOCIATED WITH THE LACTATE DEHYDROGENASE ASSAY DID NOT IDENTIFY ANY RELATED TRENDS. MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE REAGENT LOT DID NOT IDENTIFY ANY ISSUES. ADDITIONALLY, LABELING WAS REVIEWED WHICH SUFFICIENTLY ADDRESSES THE CUSTOMERS ISSUE. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT LACTATE DEHYDROGENASE ASSAY WAS IDENTIFIED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A. PATIENT INFORMATION: NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER.

Description of Event or Problem

THE CUSTOMER OBSERVED ERRATIC ARCHITECT LACTATE DEHYDROGENASE (LDH) ASSAY RESULTS FOR ONE PATIENT SAMPLE. SAMPLE ID (B)(6) WAS TESTED MULTIPLE TIMES ACROSS TWO ANALYZERS. THE SAMPLE GENERATED ELEVATED RESULTS OF 295.96 AND 258.68 U/L AND NORMAL RESULTS OF 210.55 U/L, 199.29 AND 187.71 U/L. THE CUSTOMERS REFERENCE RANGE IS 125 TO 220 U/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.