CLINICAL CHEMISTRY LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

PATIENT IDENTIFIER: MULTIPLE = (B)(6). ALL THERE IS NO FURTHER PATIENT INFORMATION PROVIDED DUE TO PRIVACY ISSUES. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED LDH RESULTS ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL PLASMA SAMPLE = 418U/L / REPEAT = 236U/L; SID (B)(6) SERUM SAMPLE = 264 / 270U/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

INSTRUMENT LOGS WERE PULLED FOR THE CUSTOMER INSTRUMENT. THE QUALITY CONTROL (QC) APPEARS TO BE PERFORMING AS EXPECTED DURING THE TIME THE COMPLAINT WAS REGISTERED INDICATING THE REAGENT WAS PERFORMING AS EXPECTED AT THAT TIME. A REVIEW OF ALL COMPLAINTS ASSOCIATED WITH THE LDH ASSAY (LIST NUMBER 2P56, LOT NUMBER 12577UN18) AND A REVIEW FOR COMPLAINT TRENDS AND CORRECTIVE ACTIONS FOR THE LIST NUMBER WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY TRENDS OR NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. NO PRODUCT DEFICIENCY WAS IDENTIFIED.