BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CEA ASSAY

    MDR report key: 3140127 · Received May 31, 2013

    Report

    Report Number
    1219913-2013-00134
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    DHX
    PMA / PMN Number
    K981478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CEA RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION FO THE DEVICE IS REQUIRED. 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 · 1

    A LOW ADVIA CENTAUR XP CEA RESULT WAS OBTAINED ON A PATIENT SAMPLE. REPEAT TESTING WAS PERFORMED AND THE RESULTS WERE LOW. THE PATIENT SAMPLE WAS TESTED ON TWO DIFFERENT ALTERNATE METHODS AND THE RESULTS WERE POSITIVE. THE PATIENT'S HEALTH CHECKUP IS THE REASON FOR CEA MEASUREMENTS AND DUE TO NO INDICATION OF A CANCER DIAGNOSIS. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CEA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242138 ADVIA CENTAUR XP CEA ASSAY CEA IMMUNOASSAY DHX SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 148

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR