BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP PROSTATE-SPECIFIC ANTIGEN (PSA) ASSAY

    MDR report key: 2200118 · Received August 10, 2011

    Report

    Report Number
    1219913-2011-00109
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MTF
    PMA / PMN Number
    P950021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT PSA RESULT IS UNKNOWN. THE QUALITY CONTROL WAS WITHIN ACCEPTABLE RANGE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "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 CONJUNCTIONS 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."

    Description of Event or Problem · 1

    A LOW ADVIA CENTAUR XP PSA RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PHYSICIAN REQUESTED TESTING TO BE REPEATED FOR THE PATIENT SAMPLE. THE DILUTED RESULT WAS HIGHER. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PSA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP PROSTATE-SPECIFIC ANTIGEN (PSA) ASSAY PSA IMMUNOASSAY MTF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 228

    Patients

    Seq Age Sex Outcome Treatment
    1