ADVIA CENTAUR CEA ASSAY

Additional Manufacturer Narrative

MDR 1219913-2014-00300 WAS FILED ON DECEMBER 2, 2014 REPORTING A NON-REPRODUCIBLE ELEVATED ADVIA CENTAUR CEA RESULT.DECEMBER 18, 2014 ADDITIONAL INFORMATION.THE CONTACT NAME OF THE CUSTOMER WAS NOT AVAILABLE AT THE TIME OF THE INITIAL FILING. THE NAME WALTER VAN GERVEN WAS SUBSEQUENTLY PROVIDED TO SIEMENS.

Description of Event or Problem

CUSTOMER OBSERVED AN ELEVATED ADVIA CENTAUR CARCINOEMBRYONIC ANTIGEN (CEA) RESULT COMPARED TO HISTORICAL RESULTS. THE PATIENT HAD ADDITIONAL TESTS SUCH AS A SCAN WHICH LED THE PHYSICIAN TO QUESTION THE ELEVATED RESULT. THE SAMPLE WAS RE-TESTED AND RESULTS AGREED WITH THE HISTORICAL RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES BASED ON THE ELEVATED ADVIA CENTAUR CEA RESULT.

Additional Manufacturer Narrative

THE CAUSE FOR THE INITIAL FALSELY ELEVATED ADVIA CENTAUR CEA RESULT 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. DUE TO THE DELAY IN REPORTING THE EVENT TO SIEMENS, NO INVESTIGATION IS POSSIBLE AT THIS TIME. THE CUSTOMER REVIEWED OTHER RESULTS GENERATED JUST PRIOR TO AND JUST AFTER THE FALSELY ELEVATED RESULT AND CONCLUDED NO REMARKABLE RESULTS GENERATED AT THAT PARTICULAR PERIOD OF TIME. PRE-ANALYTICAL ERROR CANNOT BE RULED OUT. 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.