ADVIA CENTAUR XP CEA ASSAY

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE CAUSE OF THE DISCORDANT ADVIA CENTAUR XP CEA RESULTS. THE INSTRUCTION FOR USE (IFU) LIMITATION 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." MDR 1219913-2018-00230 WAS FILED FOR THE SAME EVENT.

Description of Event or Problem

DISCORDANT NEGATIVE ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED ON A PATIENT SAMPLE DURING PHYSICAL EXAMINATION. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE POSITIVE. THERE IS NO INDICATION OF A CANCER DIAGNOSIS WITH THIS PATIENT AND THE INITIAL NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS TESTED ON THE ALTERNATE METHODS BECAUSE TWO WEEKS AGO THE PATIENT WAS TESTED IN ANOTHER HOSPITAL ON THE TWO ALTERNATE METHODS AND THE RESULTS WERE POSITIVE FOR CEA. BEFORE MEASURING CEA ON THE ADVIA CENTAUR XP, THIS PATIENT TOLD THE PHYSICIAN THE PREVIOUS CEA RESULTS WERE POSITIVE. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CEA RESULTS.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2018-00231 ON SEPTEMBER 6, 2018. ON 09/17/2018 - ADDITIONAL INFORMATION: THE PATIENT SERUM CANNOT BE RETURNED DUE TO CHINA CUSTOMS ISSUES. THERE IS NO INDICATION OF A CANCER DIAGNOSIS WITH THIS PATIENT. SIEMENS HEALTHCARE DIAGNOSTICS CONTINUES TO INVESTIGATE. MDR 1219913-2018-00230 SUPPLEMENTAL REPORT 1 WAS FILED FOR THE SAME EVENT.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2018-00231 ON SEPTEMBER 6, 2018. SIEMENS FILED THE MDR 1219913-2018-00231 SUPPLEMENTAL REPORT 1 ON SEPTEMBER 25, 2018. 10/04/2018 ADDITIONAL INFORMATION: THE PATIENT SAMPLE CAN NOT BE PROVIDED FOR ADDITIONAL TESTING DUE TO CHINA CUSTOMS REGULATIONS. THE ADVIA CENTAUR CEA IFU (10629830_EN REV. L, 2015-01) STATES "THE CONCENTRATION OF CEA IN A GIVEN SPECIMEN, AS DETERMINED BY ASSAYS FROM DIFFERENT MANUFACTURERS, CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. THE RESULTS REPORTED BY THE LABORATORY TO THE PHYSICIAN MUST INCLUDE THE IDENTITY OF THE CEA ASSAY USED. VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY. IF, IN THE COURSE OF MONITORING A PATIENT, THE ASSAY METHOD USED FOR DETERMINING SERIAL CEA LEVELS IS CHANGED, THE LABORATORY MUST PERFORM ADDITIONAL SERIAL TESTING TO CONFIRM BASELINE VALUES." FOR TUMOR MARKERS, IT IS NOT RECOMMENDED THAT PATIENT RESULTS ARE COMPARED ACROSS DIFFERENT PLATFORMS AS EACH ASSAY USES A DIFFERENT ANTIBODY WHICH WILL PICK UP DIFFERENT EPITOPES ON THE CIRCULATING TUMOR MARKER WHICH CAN VARY FROM PATIENT TO PATIENT. HENCE DIFFERENT METHODS MAY GIVE SIGNIFICANTLY DIFFERENT RESULTS, DEPENDING ON THE EPITOPE DISPLAYED. BASED ON THE INFORMATION PROVIDED, SIEMENS IS UNABLE TO RULE OUT A SAMPLE SPECIFIC ISSUE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2018-00230 SUPPLEMENTAL REPORT 2 WAS FILED FOR THE SAME EVENT.