ADVIA CENTAUR XP CEA ASSAY

Description of Event or Problem

ELEVATED ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED ON SAMPLES FROM THREE PATIENTS. THE RESULTS WERE CONSIDERED DISCORDANT WITH THE CLINICAL HISTORY OF THE PATIENTS. REPEAT TESTING WAS PERFORMED AND THE RESULTS WERE LOWER. THE PATIENT SAMPLES WERE ALSO TESTED ON A SECOND ADVIA CENTAUR XP AND THE RESULTS WERE LOWER. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CEA RESULT.

Additional Manufacturer Narrative

THE SIEMENS TECHNICAL APPLICATION SPECIALIST (TAS) INVESTIGATED AND NOTED THAT THE LABORATORY'S INTERNAL QUALITY CONTROL (QC) WAS SHOWING HIGH FLYERS ON QC SINCE LOADING A FRESH PACK OF REAGENT ON APRIL 5TH, 2015. THE REAGENT PACK WAS NOT VISIBLY CLUMPED AND THERE WERE NO VISIBLE FLAKES IN THE PACK. THE REAGENT PACK WAS CHANGED. A PRECISION RUN WAS PERFORMED AND NO FURTHER FLYERS HAVE BEEN SEEN. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CEA RESULTS MAY HAVE BEEN ATTRIBUTED TO THE SUSPECT REAGENT PACK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION FO THE DEVICE IS REQUIRED. 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."