BEUDAMED
    FDA Adverse Event Summary report: N

    IMMULITE 2500

    MDR report key: 2061774 · Received April 19, 2011

    Report

    Report Number
    2247117-2011-00024
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K033234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE PERFORMED A TOTAL SERVICE CALL AND VERIFIED ALL MOTOR POSITIONS. QC RESULTS WERE ALL GOOD AFTER MAINTENANCE WAS PERFORMED. THE EXACT CAUSE OF THE DISCORDANT PSA RESULT IS UNKNOWN THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT THIRD GENERATION PSA (PSA) RESULTS WERE OBTAINED ON THE IMMULITE 2500. THE RESULT WAS QUESTIONABLE AND THE SAMPLE WAS RETESTED. THE INITIAL VALUE WAS NOT REPORTED TO THE PHYSICIAN. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR TREATMENT WITHHELD BASED ON THE DISCORDANT PSA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 IMMUNO-ASSAY JJE SIEMENS HEALTHCARE DIAGNOSTICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1