ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE FIELD SERVICE REPRESENTATIVE PERFORMED ADJUSTMENTS, PERFORMED CHECKS, CLEANED THE FLOW PATHS, AND PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 110 U/L, AND THE REPEATED RESULT WAS 74 U/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 73 U/L. THE SAMPLE WAS REPEATED BECAUSE THE RESULT DIDN'T MATCH THE PATIENT'S CLINICAL PICTURE. THE REPEATED RESULT (73 U/L) WAS BELIEVED TO BE CORRECT.