BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1513026 · Received October 19, 2009

    Report

    Report Number
    2247117-2009-00041
    Event Type
    Other
    Date Received
    October 19, 2009
    Date of Event
    October 2, 2009
    Report Date
    October 7, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DGC
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER ERROR: A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE OF THE DISCORDANT INTACT PTH (IPT) RESULTS WERE DUE TO THE OPERATOR'S SAMPLE HANDLING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT INTACT PTH (IPT) RESULTS WERE OBTAINED ON TWO PT SAMPLES. THE SAMPLES WERE REPEATED, AND THE RESULTS WERE RELEASED. PTS' TREATMENTS WERE NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORT OF ADVERSE HEALTH CONSEQUENCE AS A RESULT OF THE DISCORDANT INTACT PTH (IPT) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMUNO-ASSAY ANALYZER DGC SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1