BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1353766 · Received March 27, 2009

    Report

    Report Number
    2247117-2009-00011
    Event Type
    Other
    Date Received
    March 27, 2009
    Date of Event
    March 10, 2009
    Report Date
    March 11, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DGC
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT (B)(6) RESULTS WERE DUE TO THE MALFUNCTION OF THE BEAD SENSOR / PMT POWER SUPPLY. THE FSE REPLACED THE BEAD SENSOR / PMT POWER SUPPLY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT (B)(6) RESULTS WERE OBTAINED ON TWO PT SAMPLES, GENERATED ON IMMULITE 2000. THE SAMPLES WERE REPEATED AND THE RESULTS WERE REPORTED. PTS' TREATMENTS WERE NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT (B)(6) 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