ADVIA CENTAUR XPT CEA

Additional Manufacturer Narrative

MDR 1219913-2016-00252 WAS FILED ON DECEMBER 28, 2016 REPORTING THAT THE CUSTOMER OBSERVED NINE ELEVATED ADVIA CENTAUR XPT CEA RESULTS THAT WERE LOWER UPON REPEAT TESTING. JANUARY 31, 2017 - ADDITIONAL INFORMATION: SIEMENS SERVICE REPLACED THE PINCH VALVES ALONG WITH THE ASSOCIATED TUBING AND THE ASPIRATE PROBE GUIDES, ALL OF WHICH WOULD ADD SIGNIFICANT RLU'S TO A PATIENT SAMPLE IF FOUND TO BE FAULTY, HOWEVER, NO FAULTS WERE IDENTIFIED WITH THESE PARTS. NO CONCLUSIONS CAN BE DRAWN. THE PRECISION OF THE ADVIA CENTAUR CEA ASSAY WAS CHECKED AFTER THE SYSTEM CHECK AND WAS FOUND TO BE ACCEPTABLE. BASED ON THE SERVICE ACTIVITY RELATED TO THIS COMPLAINT, IT IS INCONCLUSIVE TO DETERMINE WHAT MECHANICAL MALFUNCTION COULD HAVE CONTRIBUTED TO THE DISCORDANT RESULT.

Additional Manufacturer Narrative

THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XPT CEA RESULTS IS UNKNOWN. SERVICE WENT ON SITE AND CHECKED/PERFORMED THE FOLLOWING: REPLACED REAGENT PROBE 1 HEATER COIL, REPLACED ASP GUIDE, PINCH VALVE AND TUBING, REPLACED ACID PUMP AND ADJUSTED ACID VOLUME, ADJUSTED INCUBATION RING AND PROBE, CHECKED B/F LINE AND SAMPLING, CHECKED OTHER LINES, CHECKED CEA QC PRECISION (N=10), TM1 1.3 NG/ML 5.12 %CV, TM2 14.6 NG/ML 2.76 %CV. SYSTEM IS IN GOOD CONDITION AND THERE WERE NO PROBLEMS FOUND IN THE EVENT LOG AT THE TIME OF THE ISSUE. SIEMENS CONTINUES TO INVESTIGATE. SERVICE WENT ON SITE AND 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."

Description of Event or Problem

CUSTOMER OBSERVED NINE ELEVATED ADVIA CENTAUR XPT CEA RESULTS THAT WERE LOWER UPON REPEAT TESTING. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XPT CEA RESULTS.