CLINICAL CHEMISTRY LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

LOT/SERIAL NUMBER WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE; THEREFORE, ONLY A DI IS PROVIDED THE CUSTOMER OBSERVED DISCREPANT PATIENT RESULTS ON THE LACTATE DEHYDROGENASE (LDH) ASSAY (PART NUMBER 02P56-21, LOT NUMBER 47146UN15) ON THEIR C16000 (SERIAL NUMBER (B)(4)). THE INSTRUMENT HISTORY WAS REVIEWED AND FOUND 131 INSTANCES OF ERROR CODE 3375 WHICH MAY INDICATE THE PRESENCE OF FOAM, BUBBLES, OR FIBRIN IN THE SAMPLES. ADDITIONALLY, THERE WERE 16 INSTANCES OF ERROR CODE 0550 INDICATING THE CUVETTE WASHING WAS NOT COMPLETED. THE MAINTENANCE FILE WAS REVIEWED AND FOUND THAT THE CUVETTE WASH (6052) PROCEDURE WAS NOT COMPLETED IN APRIL BUT WAS COMPLETED SUCCESSFULLY 4 TIMES IN THE MONTH OF MAY. THIS PROCEDURE SHOULD BE COMPLETED AFTER EVERY 0550 ERROR CODE IN ORDER TO KEEP THE CUVETTES CLEAN. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. TESTING WAS PERFORMED ON LOT 47146UN15 OF LDH AND ALL TESTING SHOWS THIS LOT IS PERFORMING AS INTENDED. A REVIEW OF TICKETS DETERMINED THAT THERE IS A NORMAL ACTIVITY FOR THE LOT 47146UN15 AND THERE ARE NO TRENDS IDENTIFIED. A REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE LOT. A MALFUNCTION WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. HOWEVER, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED. USE ERROR MAY HAVE CONTRIBUTED TO THE CUSTOMER'S ISSUE AS ERROR CODES INDICATE DIRTY CUVETTES WHICH MAY CONTRIBUTE TO FALSE RESULTS.

Description of Event or Problem

THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY ELEVATED LDH RESULTS ON FOUR PATIENTS. THE RESULTS PROVIDED WERE: (B)(6). THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.