ADVIA CENTAUR CP CEA ASSAY

Additional Manufacturer Narrative

MDR 1219913-2015-00203 WAS FILED ON DECEMBER 9, 2015 REPORTING A LOW RESULT WITH THE ADVIA CENTAU CP ASSAY THAT WAS QUESTIONED BY THE PHYSICIAN AND DID NOT MATCH THE RESULT BY AN ALTERNATE METHOD WHEN SENT OUT FOR ADDITIONAL TESTING. ON 01/5/2016 - ADDITIONAL INFORMATION SIEMENS SERVICE WENT ON SITE AND PERFORMED AN INSPECTION OF THE FULL SYSTEM AND INSTALLED PARTS OF AN ANNUAL CERTIFICATION KIT. THE ENGINEER, UPON NOTING THAT THE REAGENT PROBE WAS BENT, REPLACED THE PROBE. THE ENGINEER FOUND THE SHUTTERS STICKING AND CLEANED THEM. HE FOUND THE REAGENT SYRINGE HAD A LEAK AND REPLACED THE SYRINGE. HE ALSO FOUND A LEAK IN THE REAR RINSE BLOCK WHICH HE REPLACED. HE RAN ASP AND DISP CHECKS WHICH ALL PASSED. HE ALIGNED THE PROBES AND RAN QC AND NOTED THAT QC PASSED. A REVIEW OF THIS INFORMATION INDICATES THAT A BENT OR DRIPPING REAGENT PROBE COULD HAVE CAUSED LOWER RLUS AND THEREFORE A LOW RESULT. THE CUSTOMER ALSO PROVIDED DATA FOR A SECOND PATIENT. THE PATIENT WAS TESTED ON (B)(6) 2015 AND RESULTED AS <1 NG/ML, HOWEVER, THE RESULT FROM A DIFFERENT LAB WAS 336.5 NG/ML ON (B)(6) 2015.

Additional Manufacturer Narrative

THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR CP CEA RESULT IS UNKNOWN. CUSTOMER STATED THAT THERE HAVE BEEN NO ISSUES WITH QUALITY CONTROL MATERIAL. CALIBRATION DATA FROM THE CALIBRATION IN USE WHEN THE LOW RESULT WAS OBTAINED WAS NOT PROVIDED, HOWEVER, CALIBRATION DATA FROM THE DAY AFTER THE EVENT WAS ACCEPTABLE. SIEMENS WENT ON SITE TO TROUBLESHOOT THE ISSUE ON DECEMBER 14, 2015. SEVERAL CALIBRATIONS WERE ATTEMPTED USING ADVIA CENTAUR CP CEA REAGENT LOT 040162 BUT ALL FAILED. A NEW SHIPMENT OF REAGENT LOT 040162, CALIBRATORS AND MASTER CURVE MATERIAL WERE SENT TO THE CUSTOMER. THE CUSTOMER OBTAINED A VALID CALIBRATION WITH THE NEW SHIPMENT. MASTER CURVE MATERIAL WAS IN RANGE. NO CONCLUSIONS CAN BE DRAWN. THE LIMITATIONS SECTION OF THE INSTRUCTIOSN FOR USE (IFU) 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 A LOW RESULT WITH THE ADVIA CENTAUR CP CEA ASSAY THAT WAS QUESTIONED BY THE PHYSICIAN AND DID NOT MATCH THE RESULT BY AN ALTERNATE METHOD WHEN SENT OUT FOR ADDITIONAL TESTING. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR CP CEA RESULT.