BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1070028 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05202
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 12, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOUR PTS WITH DISCREPANT SODIUM RESULTS. PT 1, INITIAL RESULT 131 MMOL/L, REPEATED TWICE GAVE 139 (DIFFERENT METHODOLOGY) AND 137 MMOL/L. PT 2, INITIAL RESULT 133 MMOL/L, REPEATED THREE TIMES GAVE 138 (DIFFERENT METHODOLOGY), 139 AND 138 MMOL/L. PT 3, INITIAL RESULT OF 131 MMOL/L, REPEATED TWICE GAVE 140 (DIFFERENT METHODOLOGY) AND 137 MMOL/L. PT 4, INITIAL RESULT 133 MMOL/L, REPEATED TWICE GAVE 139 (DIFFERENT METHODOLOGY) AND 138 MMOL/L. ERRONEOUS RESULTS WERE NOT REPORTED. USER PERFORMED RECOMMENDED MAINTENANCE AND TROUBLESHOOTING WHICH INCLUDED ELECTRODE ETCHING AND ISE TUBING CONDITIONING THAT RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER -JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK