BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 1052717 · Received May 23, 2008

    Report

    Report Number
    1823260-2008-04293
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K071211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT BICARBONATE (CO2) RESULTS. INITIAL RESULT GAVE 13 MMOL/L; REPEATED TWICE GAVE 20 AND 27 MMOL/L. INITIAL RESULT WAS REPORTED. PT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP DETERMINED THE CAUSE OF THE DISCREPANCY TO BE DUE TO LOOSE FITTING FOR THE CLEANER SOLUTION AND TIGHTENED/ADJUSTED THE FITTING. PERFORMANCE TESTING WAS PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS C111 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS C111

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR