BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C501

    MDR report key: 966041 · Received May 10, 2007

    Report

    Report Number
    1823260-2007-03989
    Event Type
    Malfunction
    Date Received
    May 10, 2007
    Date of Event
    April 24, 2007
    Report Date
    May 10, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATES THEY HAVE EXPERIENCED ONGOING ISSUES WITH DRIFTING SODIUM RESULTS. THE FOLLOWING 3 PT SODIUM RESULTS WERE PROVIDED: INITIAL RESULTS WERE 129/132/127 MMOI/L. WHEN REPEATED THE RESULTS WERE 136/138/133 MMOI/L RESPECTIVELY. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS C501 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA