BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CEA ASSAY

    MDR report key: 5651266 · Received May 12, 2016

    Report

    Report Number
    1219913-2016-00081
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    April 6, 2016
    Report Date
    August 16, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    DHX
    PMA / PMN Number
    P950021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSELY LOW ADVIA CENTAUR XP RESULTS IS UNKNOWN. SIEMENS HAS REQUESTED ADDITIONAL INCIDENT INFORMATION. THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION NOTE SECTION STATES THE FOLLOWING: "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."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00081 ON 05/12/2016 FOR A FALSE LOW ADVIA CENTAUR XP CEA PATIENT RESULT. ON 05/19/2016 ADDITIONAL INFORMATION: THE REAGENT LOT NUMBER HAS BEEN PROVIDED. THE PATIENT IS NOT TAKING ANY MEDICATION AND APPEARS TO BE IN REMISSION. THE PATIENT SAMPLE HAS BEEN RECEIVED BY SIEMENS FOR FURTHER TESTING. ADVIA CENTAUR XP REAGENT LOT NUMBER 040163, EXPIRATION DATE: 11/04/2016, MANUFACTURING DATE: 11/04/2015.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00081 ON 05/12/2016 FOR A FALSE LOW ADVIA CENTAUR XP CEA PATIENT RESULT. MDR 1219913-2016-00081 SUPPLEMENTAL REPORT 1 WAS FILED ON 06/14/2016 FOR ADDITIONAL PATIENT AND REAGENT LOT INFORMATION, AND MDR 1219913-2016-00081 SUPPLEMENTAL REPORT 2 FOR ADDITIONAL INVESTIGATION INFORMATION. ON 08/12/16 ADDITIONAL INFORMATION: THE CUSTOMER CONTACTED ONE OF THE ALTERNATE LABORATORIES WITH REGARDS TO THE HIGHER CEA PATIENT RESULT COMPARED TO THE ADVIA CENTAUR XP CEA LOWER RESULT. THE ALTERNATE LABORATORY ANALYZED THE PATIENT SAMPLE FOR HETEROPHLIIC ANTIBODIES AND FOUND THAT THE HIGHER CEA TEST METHOD (COBAS E601) RESULT WAS DUE TO HETEROPHILIC INTERFERENCE. BASED ON THE HETEROPHILIC INTERFERENCE FOUND BY THE ONE ALTERNATE LABORATORY CEA TEST METHOD (COBAS 3601), THE LOWER ADVIA CENTAUR XP CEA RESULT WOULD BE CONSIDERED CORRECT. THE INSTRUMENT IN PERFORMING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00081 ON 05/12/2016 FOR A FALSE LOW ADVIA CENTAUR XP CEA PATIENT RESULT, AND MDR 1219913-2016-00081 SUPPLEMENTAL REPORT 1 ON 06/14/2016 FOR ADDITIONAL PATIENT AND REAGENT LOT INFORMATION. UPDATE 06/23/16 ADDITIONAL INFORMATION: SIEMENS TESTED THE RETURNED PATIENT SAMPLES ON TWO DIFFERENT ADVIA CENTAUR CEA REAGENT LOTS, AND ON AN ALTERNATE CEA TEST METHOD (DIMENSION VISTA) AND OBTAINED LOW CEA RESULTS. THE PATIENT SAMPLES WERE TREATED WITH A HETEROPHILIC BLOCKING TUBE (HBT) AND THE CEA RESULTS WERE SIMILAR, INDICATING NO HETEROPHILIC ANTIBODIES INTERFERENCE WITH THE ASSAY. THE CAUSE FOR THE LOW ADVIA CENTAUR XP CEA RESULTS COMPARED TO HIGHER CEA RESULTS ON TWO OTHER ALTERNATE TEST METHODS THAT THE CUSTOMER OBSERVED IS UNKNOWN. NO CONCLUSION CAN BE DRAWN. SIEMENS CEA TEST RESULTS (NG/ML): (B)(6). THE INSTRUMENT IN PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSE LOW ADVIA CENTAUR XP CEA RESULT WAS OBTAINED ON A PATIENT SAMPLE THAT DID NOT MATCH THE RESULTS BY ALTERNATE CEA TEST METHODS. THE ADVIA CENTAUR XP LOW RESULT WAS QUESTIONED BY THE PHYSICIAN, AND REPEAT TESTING WAS PERFORMED AT TWO OTHER LABORATORIES WITH AN ALTERNATE CEA TEST METHOD, AS WELL AS ONE OTHER ANOTHER LABORATORY WITH AN ADVIA CENTAUR XP SYSTEM. THE ALTERNATE CEA TEST METHODS RESULTS WERE HIGHER, COMPARED TO THE LOWER ADVIA CENTAUR XP CEA RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR XP CEA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305080 ADVIA CENTAUR XP CEA ASSAY CEA IMMUNOASSAY DHX SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 040163

    Patients

    Seq Age Sex Outcome Treatment
    1