BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP PSA ASSAY

    MDR report key: 3882117 · Received June 18, 2014

    Report

    Report Number
    1219913-2014-00148
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 24, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MTF
    PMA / PMN Number
    P950021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSE LOW PSA PATIENT RESULT ON THE ADVIA CENTAUR XP SYSTEM WHEN COMPARE TO THE PATIENT'S PSA TEST HISTORY, A HIGHER RESULT FROM A NEW PATIENT SAMPLE DRAW RUN AT AN ALTERNATE LABORATORY AND THE HIGHER PSA RESULTS WHEN THE ORIGINAL SAMPLE WAS REPEATED IS UNKNOWN. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE LIMITS AND THERE WERE NO ERRORS OBSERVED IN THE SYSTEM LOG AT THE TIME OF THE DISCORDANT RESULT HOWEVER, THE CUSTOMER DID OBSERVE A LOT OF FIBRIN STRANDS IN THE PATIENT SAMPLE. THE CUSTOMER REPEATED THE PATIENT SAMPLES THAT WERE RUN PRIOR TO AND FOLLOWING THE DISCORDANT SAMPLE AND THE PSA TEST RESULTS WERE CORRECT. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE UNDER THE LIMITATION SECTION STATES THE FOLLOWING: "NOTE: DO NOT INTERPRET LEVELS OF PSA AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE. BEFORE TREATMENT, PATIENTS WITH CONFIRMED PROSTATE CARCINOMA FREQUENTLY HAVE LEVELS OF PSA WITHIN THE RANGE OBSERVED IN HEALTHY INDIVIDUALS. ELEVATED LEVELS OF PSA CAN BE OBSERVED IN PATIENTS WITH NONMALIGNANT DISEASES. MEASUREMENTS OF PSA SHOULD ALWAYS BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION." "THE CONCENTRATION OF TOTAL PSA IN A GIVEN SPECIMEN DETERMINED WITH ASSAYS FROM DIFFERENT MANUFACTURERS' CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS, CALIBRATION, AND REAGENT SPECIFICITY. TOTAL PSA DETERMINED WITH DIFFERENT MANUFACTURERS ASSAYS WILL VARY DEPENDING ON THE METHOD OF STANDARDIZATION AND ANTIBODY SPECIFICITY. WARNING: DO NOT PREDICT DISEASE RECURRENCE SOLELY ON SERIAL PSA VALUES." THE INSTRUCTION FOR USE UNDER THE SPECIMEN COLLECTION AND HANDLING SECTION STATES THE FOLLOWING: "BEFORE PLACING SAMPLES ON THE SYSTEM ENSURE THAT SAMPLES HAVE THE FOLLOWING CHARACTERISTICS: "SAMPLES ARE FREE OF FIBRIN OR OTHER PARTICULATE MATTER." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSE LOW ADVIA CENTAUR XP PSA RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE AND THE LOW RESULT WAS QUESTIONED BY THE PHYSICIAN. THE LOW PSA RESULT WAS CONSIDERED DISCORDANT WHEN COMPARE TO THE PATIENT'S PSA TEST HISTORY. A NEW PATIENT SAMPLE WAS DRAWN AND SENT TO AN ALTERNATE LABORATORY FOR PSA TESTING AND THE RESULT WAS HIGHER. THE ORIGINAL PATIENT SAMPLE WAS REPEATED ON THE ADVIA CENTAUR XP AND THE RESULTS WERE HIGHER. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW ADVIA CENTAUR XP PSA TEST RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358323 ADVIA CENTAUR XP PSA ASSAY PSA IMMUNOASSAY, PRODUCT CODE: MTF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 254

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR