ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION

Additional Manufacturer Narrative

CALIBRATION AND CONTROL DATA WERE ACCEPTABLE. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. UPON REVIEW OF THE ALARM TRACE FOR 09-DEC-2024, 12 SAMPLE FOAM DETECTION ALARMS AND ONE SAMPLE CLOT DETECTION ALARM WERE OBSERVED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C 502 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST) ON A COBAS 8000 C 502 MODULE. THE SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 93.9 U/L. THE PATIENT QUESTIONED THE RESULT, SO THE SAMPLE WAS REPEATED. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN AN AST VALUE OF 20.6 U/L. A SECOND TUBE COLLECTED AT THE SAME TIME WAS ALSO REPEATED ON A SECOND ANALYZER ON (B)(6) 2024, RESULTING IN A VALUE OF 19.9 U/L.