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Patient 1
THE CAUSE FOR THE FALSELY HIGH ADVIA CENTAUR XPT PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT IS BEING INVESTIGATING BY SIEMENS. THE PATIENT SAMPLE HAS BEEN REQUESTED FOR FURTHER TESTING. THE INSTRUCTION FOR USE (IFU) UNDER THE INTENDED USE SECTION STATES THE FOLLOWING: "THIS IN VITRO DIAGNOSTIC ASSAY IS INTENDED TO QUANTITATIVELY MEASURE PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ADVIA CENTAUR?, ADVIA CENTAUR XP, AND ADVIA CENTAUR XPT SYSTEMS. THIS ASSAY IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. THIS ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PATIENTS WITH PROSTATE CANCER." THE INSTRUCTION FOR USE (IFU UNDER THE SUMMARY AND EXPLANATION SECTION STATES THE FOLLOWING: "PSA LEVELS INCREASE IN MEN WITH CANCER OF THE PROSTATE, AND AFTER RADICAL PROSTATECTOMY PSA LEVELS ROUTINELY FALL TO THE UNDETECTABLE RANGE. IF PROSTATIC TISSUE REMAINS AFTER SURGERY OR METASTASIS HAS OCCURRED, PSA APPEARS TO BE USEFUL IN DETECTING RESIDUAL AND EARLY RECURRENCE OF TUMOR. THEREFORE, SERIAL PSA LEVELS CAN HELP DETERMINE THE SUCCESS OF PROSTATECTOMY, AND THE NEED FOR FURTHER TREATMENT, SUCH AS RADIATION, ENDOCRINE OR CHEMOTHERAPY, AND IN THE MONITORING OF THE EFFECTIVENESS OF THERAPY." THE INSTRUCTION FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "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) UNDER THE LIMITATION SECTION STATES THE FOLLOWING: "WARNING" "DO NOT PREDICT DISEASE RECURRENCE SOLELY ON SERIAL PSA VALUES." "DO NOT INTERPRET LEVELS OF PSA AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE. BEFORE TREATMENT, PATIENTS WITH CONFIRMED PROSTATE CARCINOMA FREQUENTLY HAVE LEVELS OF PSA WITHIN THE RANGE OBSERVED IN HEALTHY INDIVIDUALS. ELEVATED LEVELS OF PSA CAN BE OBSERVED IN PATIENTS WITH NONMALIGNANT DISEASES. MEASUREMENTS OF PSA SHOULD ALWAYS BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION. THE CONCENTRATION OF TOTAL PSA IN A GIVEN SPECIMEN DETERMINED WITH ASSAYS FROM DIFFERENT MANUFACTURERS CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS, CALIBRATION, AND REAGENT SPECIFICITY. TOTAL PSA DETERMINED WITH DIFFERENT MANUFACTURERS' ASSAYS WILL VARY DEPENDING ON THE METHOD OF STANDARDIZATION AND ANTIBODY SPECIFICITY." MDR 1219913-2018-00151 WAS FILED PREVIOUSLY FOR A FALSELY ELEVATED RESULT ON THE SAME PATIENT. MDR 1219913-2018-00151 SUPPLEMENTAL REPORT 1 WAS FILED FOR A RESULT CORRECTION, AND ADDITIONAL INFORMATION. MDR 1219913-2018-00151 SUPPLEMENTAL REPORT 2 FOR A CORRECTION, AND PATIENT/TEST INFORMATION NOT ORIGINALLY PROVIDED.