BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1707047 · Received May 27, 2010

    Report

    Report Number
    2247117-2010-00016
    Event Type
    Other
    Date Received
    May 27, 2010
    Date of Event
    November 1, 2009
    Report Date
    May 4, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K905215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE DISCORDANT LOW B2M RESULTS WERE CAUSED BY USER/OPERATOR ERROR ASSOCIATED WITH THE CUSTOMER'S LIS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT LOW B2M RESULTS WERE REPORTED OVER THE LAST SIX MONTHS. INITIAL B2M RESULTS FOR SAMPLES DILUTED 1:40 WERE >20,000 NG/ML ON THE IMMULITE 2500 INSTRUMENT REPORT AND SOFTWARE DISPLAY. THE IMMULITE 2500 SOFTWARE SENDS RESULTS TO THE CUSTOMER LIS AS GREATER THAN THE ASSAY LIMIT (> 500 NG/ML). THE CUSTOMER'S LIS APPLIED A UNIT CORRECTION FACTOR OF 1000 TO THE RESULTS, REMOVING THE ">" SYMBOL IN THE PROCESS, AND REPORTED OUT ERRONEOUSLY LOW RESULTS OF 0.5 UG/ML. IT IS NOT KNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT B2M RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 IMMUNO-ASSAY JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1