BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP AFP ASSAY

    MDR report key: 3770673 · Received April 24, 2014

    Report

    Report Number
    1219913-2014-00099
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOJ
    PMA / PMN Number
    K020806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT AFP RESULTS IS UNKNOWN. THE PATIENT SAMPLE IS NOT AVAILABLE FOR FURTHER TESTING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE INTENDED USE SECTION: "USE AFP RESULTS ONLY AS PART OF THE OVERALL CLINICAL EVALUATION OF A PATIENT. DO NOT USE AFP RESULTS AS THE ONLY CRITERION FOR DIAGNOSIS." THE IFU STATES IN THE WARNING SECTION: "THE ADVIA CENTAUR AFP ASSAY IS NOT A SCREENING TEST FOR CANCER AND MUST NEVER BE USED AS SUCH. AFP TESTING IS A SAFE AND EFFECTIVE SUPPLEMENT TO PATIENT CARE WHEN USED AS PART OF THE OVERALL MANAGEMENT STRATEGY FOR PATIENTS UNDERGOING TREATMENT FOR NON-SEMINOMATOUS TESTICULAR CANCER OR FOR PATIENTS BEING MONITORED AFTER THERAPY IS COMPLETE. DO NOT INTERPRET SERUM AFP AS ABSOLUTE EVIDENCE OF THE PRESENCE OF MALIGNANT DISEASE. AT TIME OF PRESENTATION, PATIENTS WITH CONFIRMED NON-SEMINOMATOUS TESTICULAR CANCER MAY HAVE SERUM AFP CONCENTRATIONS WITHIN THE RANGE OBSERVED IN HEALTHY INDIVIDUALS. SINCE ELEVATED AFP LEVELS ARE OFTEN FOUND IN PATIENTS WITH OTHER MALIGNANT AND NON-MALIGNANT CONDITIONS, THE PHYSICIAN SHOULD RULE OUT ALL OTHER CONDITIONS ASSOCIATED WITH ELEVATED AFP LEVELS PRIOR TO THE USE OF THE ADVIA CENTAUR AFP VALUES IN NON-SEMINOMATOUS TESTICULAR CANCER MANAGEMENT. CONVERSELY, LOW CONCENTRATIONS OF AFP ARE NOT NECESSARILY INDICATIVE OF ABSENCE OF DISEASE, PARTICULARLY POST-SURGERY OR AFTER CHEMOTHERAPY. TESTICULAR TUMORS THAT ARE HISTOLOGICALLY CATEGORIZED AS PURE SEMINOMA DO NOT SYNTHESIZE AFP. THE ADVIA CENTAUR AFP ASSAY, AS A USEFUL ADJUNCT IN CANCER MANAGEMENT, IS INTENDED FOR THE EVALUATION OF NON-SEMINOMATOUS TESTICULAR CANCER, OR MIXED TUMORS WITH NON-SEMINOMATOUS ELEMENTS, BUT NOT FOR PURE SEMINOMA. ADDITIONALLY, SEVERAL HISTOLOGIC SUBTYPES OF NON-SEMINOMA EITHER DO NOT SYNTHESIZE AFP (CHORIOCARCINOMA) OR DO SO UNPREDICTABLY (TERATOMA). THEREFORE, AFP LEVELS SHOULD BE USED CONCURRENTLY WITH OTHER DIAGNOSTIC AND CLINICAL PATIENT INFORMATION."

    Description of Event or Problem · 1

    A FALSE LOW ADVIA CENTAUR XP AFP RESULT WAS OBTAINED FOR A PATIENT SAMPLE. REPEAT TESTING WAS PERFORMED ON THE PATIENT SAMPLE AND THE RESULT WAS HIGHER. THE PATIENT SAMPLE WAS TESTED AGAIN AFTER DILUTION AND THE RESULT WAS HIGHER. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249305 ADVIA CENTAUR XP AFP ASSAY AFP IMMUNOASSAY LOJ SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 146

    Patients

    Seq Age Sex Outcome Treatment
    1