BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1456905 · Received August 26, 2009

    Report

    Report Number
    2247117-2009-00033
    Event Type
    Other
    Date Received
    August 26, 2009
    Date of Event
    July 30, 2009
    Report Date
    July 30, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JNL
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE TECHNICAL SUPPORT ENGINEER (TSE) ANALYZED THE INSTRUMENT DATA AND DETERMINED THAT THE CAUSE OF THE DISCORDANT RESULT WAS DUE TO THE SAMPLE LEVEL SENSE ERROR. THE CAUSE OF THE SAMPLE LEVEL SENSE ERROR IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULTS WERE OBTAINED ON TWO PT SAMPLES, GENERATED ON AN IMMULITE 2000. THE SAMPLES WERE REPEATED AND THE RESULTS WERE REPORTED. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1