ADVIA CENTAUR XP CEA ASSAY

Description of Event or Problem

A FALSELY ELEVATED ADVIA CENTAUR XP CEA RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE. THE PATIENT'S CEA RESULT WAS HISTORICALLY LOWER AND THE CUSTOMER PERFORMED REPEAT TESTING. THE CEA RESULTS OF THE REPEAT TESTING WERE LOWER. THE PATIENT SAMPLE WAS ALSO RUN ON ANOTHER ADVIA CENTAUR SYSTEM FOR VERIFICATION AND THE RESULT WAS LOW. THE LOW ADVIA CENTAUR XP RESULT WAS REPORTED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED ADVIA CENTAUR XP CEA RESULT.

Additional Manufacturer Narrative

THE CAUSE FOR THE INITIAL FALSELY ELEVATED ADVIA CENTAUR XP CEA RESULT WHEN COMPARED TO THE LOWER REPEAT RESULTS AND THE PATIENT'S HISTORICAL CEA TEST RESULT IS UNKNOWN. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGE LIMITS. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) LIMITATION SECTION STATES: "NOTE: DO NOT INTERPRET LEVELS OF CEA AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE. MEASUREMENTS OF CEA SHOULD ALWAYS BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION. THE CONCENTRATION OF CEA IN A GIVEN SPECIMEN DETERMINED WITH ASSAYS FROM DIFFERENT MANUFACTURERS CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS, CALIBRATION, AND REAGENT SPECIFICITY. CEA DETERMINED WITH DIFFERENT MANUFACTURERS' ASSAYS WILL VARY DEPENDING ON THE METHOD OF STANDARDIZATION AND ANTIBODY SPECIFICITY. WARNING: DO NOT USE THE ADVIA CENTAUR CEA IMMUNOASSAY AS A SCREENING TEST FOR DIAGNOSIS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.