BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1874233 · Received October 12, 2010

    Report

    Report Number
    2247117-2010-00043
    Event Type
    Other
    Date Received
    October 12, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 27, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DGC
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE IMMULITE 2000 INSTRUMENT DATA. THE TSE CONCLUDED THAT THE CAUSE OF THE DISCREPANT CA15-3 RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW IMMULITE 2000 CA15-3 RESULT WAS OBTAINED FOR ONE (1) PT SAMPLE. THE PHYSICIAN QUESTIONED THE RESULT DUE TO THE PT'S HISTORY, AND THE SAMPLE WAS RE-TESTED. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA15-3 RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1