ADVIA CENTAUR XP CEA ASSAY

Additional Manufacturer Narrative

THE CUSTOMER OBSERVED FLOATING FIBRIN IN SERUM OF THE PATIENT SAMPLE. THE ADVIA CENTAUR XP CEA IFU (10629830_EN REV. M, 2019-02) STATES TO MAKE SURE "SAMPLES ARE FREE OF FIBRIN OR OTHER PARTICULATE MATTER. REMOVE PARTICULATES BY CENTRIFUGATION AT 1000 X G FOR 15-20 MINUTES." PRE-ANALYTIC VARIABLES CAN AFFECT THE QUALITY OF THE SAMPLE, AND DEVIATION FROM RECOMMENDED BEST PRACTICES CAN LEAD TO ERRONEOUS RESULTS. SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS SUCH AS FIBRIN BEING PRESENT IN THE SAMPLE AS THE CAUSE FOR THE NON-REPRODUCIBLE RESULTS. BASED ON THE INFORMATION PROVIDED, NO PRODUCT PROBLEM IDENTIFIED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUCTION FOR USE (IFU) IN THE INTERPRETATION OF RESULTS SECTION STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." THE INSTRUCTION FOR USE (IFU) IN THE LIMITATIONS SECTION STATES: "WARNING DO NOT USE THE ADVIA CENTAUR CEA IMMUNOASSAY AS A SCREENING TEST FOR DIAGNOSIS. 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."

Description of Event or Problem

A FALSELY ELEVATED ADVIA CENTAUR XP CEA RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE ELEVATED RESULT WAS REPORTED TO THE CLINICIAN AND WAS QUESTIONED. THE LABORATORY QUERIED THE PAST RESULTS AND WERE ALL NEGATIVE. THE PATIENT SAMPLE WAS REPEATED ON ANOTHER ADVIA CENTAUR XP AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS REPEATED ON THE INITIAL ADVIA CENTAUR XP AND THE RESULT WAS NEGATIVE. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CEA RESULTS.