ADVIA CENTAUR CEA ASSAY

Description of Event or Problem

CUSTOMER OBSERVED THREE PATIENT RESULTS THAT WERE INITIALLY ELEVATED FOR ADVIA CENTAUR CARCINOEMBRYONIC ANTIGEN (CEA). THE ELEVATED RESULTS DID NOT REPEAT UPON RETESTING OF THE ORIGINAL SAMPLES ON A DIFFERENT ADVIA CENTAUR WITH THE SAME REAGENT LOT AND CALIBRATOR LOT COMBINATION SEVERAL DAYS LATER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES BASED ON THE ELEVATED ADVIA CENTAUR CEA RESULTS.

Additional Manufacturer Narrative

THE CAUSE FOR THE INITIAL FALSELY ELEVATED ADVIA CENTAUR CEA RESULTS WHEN COMPARED TO THE LOWER REPEAT RESULTS IS UNKNOWN. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGE LIMITS. NO CONCLUSION CAN BE DRAWN. THE SAMPLE HANDLING SECTION OF THE INSTRUCTIONS FOR USE STATES: "FREEZE SAMPLES AT OR BELOW -20C IF THE SAMPLE IS NOT ASSAYED WITHIN 48 HOURS." IT IS UNKNOWN HOW THE SAMPLES WERE STORED PRIOR TO THE REPEAT TESTING. NO CONCLUSIONS CAN BE DRAWN. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) 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.

Additional Manufacturer Narrative

THE INITIAL MDR 1219913-2014-00288 WAS FILED ON NOVEMBER 13, 2014 REPORTING THREE PATIENT RESULTS THAT WERE INITIALLY ELEVATED FOR ADVIA CENTAUR CARCINOEMBRYONIC ANTIGEN (CEA). THE ELEVATED RESULTS DID NOT REPEAT UPON RETESTING. ADDITIONAL INFORMATION DECEMBER 12, 2014. THE CUSTOMER CONFIRMED THAT SAMPLES ARE STORED REFRIGERATED FOR APPROXIMATELY 5 DAYS AND SAMPLES ARE NOT STORED FROZEN AT OR BELOW -20C. THE CUSTOMER HAS IMPLEMENTED CRITERIA TO HOLD SAMPLES WITH POSITIVE RESULTS. SINCE THE IMPLEMENTATION OF THE CRITERIA, THE CUSTOMER HAS NOT NOTED ANY ADDITIONAL DISCREPANT TEST RESULTS.