ADVIA CENTAUR XP CARCINOEMBRYONIC ANTIGEN (CEA)

Additional Manufacturer Narrative

SIEMENS FILED MDR 1219913-2020-00203 ON AUGUST 7, 2020 REPORTING AN ADVIA CENTAUR XP CEA RESULT THAT WAS ELEVATED COMPARED TO REPEAT TESTING. SEPTEMBER 1, 2020 - ADDITIONAL INFORMATION: THE INITIAL ADVIA CENTAUR XP CEA LOT 040195/CD09 RESULT WAS ELEVATED. THE SAMPLE WAS REPEATED MULTIPLE TIMES AND ON DIFFERENT ADVIA CENTAUR XP SYSTEMS AND RESULTED <0.5 NG/ML. SIEMENS REVIEWED THE SAMPLE HANDLING AND PRE-ANALYTICAL FACTORS. THE SAMPLE WAS INITIALLY RUN ON (B)(6) 2020 AND REPEATED ON (B)(6) 2020. THE SAMPLE WAS STORED AT 2-8C BETWEEN (B)(6) 2020. THE SAMPLE BEFORE BEING TESTED ON (B)(6) 2020 CAME FROM A CLINIC AND SPUN ON (B)(6) 2020 AT THE LOCAL BRANCH AND THEN SENT TO THIS CUSTOMER AND RECEIVED ON (B)(6) 2020 FOR TESTING. THERE WAS NO ADDITIONAL HANDLING PRIOR TO SAMPLE TESTING ON(B)(6) 2020. THE ADVIA CENTAUR CEA IFU (10629830_EN REV. N, 2020-04) STATES IN THE SPECIMEN COLLECTION AND HANDLING SECTION "TIGHTLY CAP AND REFRIGERATE SPECIMENS AT 2-8°C IF THE ASSAY IS NOT COMPLETED WITHIN 8 HOURS. FREEZE SAMPLES AT OR BELOW -20°C IF THE SAMPLE IS NOT ASSAYED WITHIN 48 HOURS." PRE-ANALYTIC VARIABLES CAN AFFECT THE QUALITY OF THE SAMPLE, AND DEVIATION FROM RECOMMENDED BEST PRACTICES CAN LEAD TO ERRONEOUS RESULTS. WHILE THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE NON-REPRODUCIBLE HIGH RESULT, SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS OR SAMPLE SPECIFIC ISSUE. NO PRODUCT PROBLEM WAS IDENTIFIED. THE CUSTOMER IS OPERATIONAL. NO FURTHER ACTION IS NEEDED.

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. 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

THE CUSTOMER OBSERVED AN ADVIA CENTAUR XP CARCINOEMBRYONIC ANTIGEN (CEA) RESULT THAT WAS ELEVATED COMPARED TO REPEAT TESTING. THE ELEVATED RESULT WAS NOT REPORTED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP CEA RESULT.