BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1408771 · Received June 29, 2009

    Report

    Report Number
    2247117-2009-00023
    Event Type
    Other
    Date Received
    June 29, 2009
    Date of Event
    June 9, 2009
    Report Date
    June 9, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LTK
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT CA-125 (OV) RESULT WAS OBTAINED ON PATIENT SAMPLE. THE SAMPLE WAS REPEATED AND THE CORRECT CA-125 (OV) RESULT WAS REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OR ADVERSE HEALTH CONSEQUENCE AS A RESULT OF THE DISCORDANT CA-125 (OV) RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1