BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1423657 · Received April 3, 2009

    Report

    Report Number
    1823260-2009-02454
    Event Type
    Malfunction
    Date Received
    April 3, 2009
    Date of Event
    March 14, 2009
    Report Date
    April 3, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. HE VERIFIED THE ISE'S WERE PERFORMING OPTIMALLY AND COMPLETED AN ISE PERFORMANCE CHECKLIST. CALIBRATION AND QC WERE PERFORMED TO VERIFY THE ANALYZER PERFORMANCE.

    Description of Event or Problem · 1

    THE USER HAD A SAMPLE FROM A PT WITH AN IGM MONOCLONAL GAMMOPATHY, CAUSING THE SAMPLE TO BE VISCOUS. SHE WAS GETTING SODIUM READINGS BETWEEN 100-120 MMOL PER L ON RERUN WITH NO ERRORS. THE SPECIFIC RESULTS FROM THIS ANALYZER IN MMOL PER L ARE AS FOLLOWS 120, 117, 100, 120, 120 AND 117. THE ERRONEOUS RESULTS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR