BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 PSA

    MDR report key: 1240873 · Received November 6, 2008

    Report

    Report Number
    2017183-2008-00047
    Event Type
    Other
    Date Received
    November 6, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 17, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LTJ
    PMA / PMN Number
    P930027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE LOW DISCORDANT PSA RESULT IS UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A LOW POSITIVE IMMULITE 2000 PSA RESULT WAS OBTAINED ON A PATIENT SAMPLE. MULTIPLE RETESTING OF THE PATIENT SAMPLE RESULTED IN HIGHER PSA VALUES. THE LOW PSA RESULT WAS NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW PSA ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 PSA PSA IMMUNOASSAY LTJ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 278

    Patients

    Seq Age Sex Outcome Treatment
    1