BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400+

    MDR report key: 1780973 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06554
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    July 6, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT EXPERIENCED FOUR LOW PATIENT SODIUM RESULTS THAT WERE HIGHER WHEN REPEATED. THE RESULTS WERE AS FOLLOWS (INITIAL/REPEAT AT ANOTHER FACILITY/REPEAT ON THE SAME SYSTEM MMOL/L): SAMPLE 1 132/141/142. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANT RESULTS.

    Description of Event or Problem · 2

    ACCOUNT EXPERIENCED FOUR LOW PATIENT SODIUM RESULTS THAT WERE HIGHER WHEN REPEATED. THE RESULTS WERE AS FOLLOWS (INITIAL/REPEAT AT ANOTHER FACILITY/REPEAT ON THE SAME SYSTEM MMOL/L): SAMPLE 2 120/129/129. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANT RESULTS.

    Description of Event or Problem · 3

    ACCOUNT EXPERIENCED FOUR LOW PATIENT SODIUM RESULTS THAT WERE HIGHER WHEN REPEATED. THE RESULTS WERE AS FOLLOWS (INITIAL/REPEAT AT ANOTHER FACILITY/REPEAT ON THE SAME SYSTEM MMOL/L): SAMPLE 3 128/139/139. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANT RESULTS.

    Description of Event or Problem · 4

    ACCOUNT EXPERIENCED FOUR LOW PATIENT SODIUM RESULTS THAT WERE HIGHER WHEN REPEATED. THE RESULTS WERE AS FOLLOWS (INITIAL/REPEAT AT ANOTHER FACILITY/REPEAT ON THE SAME SYSTEM MMOL/L): SAMPLE 4 128/138/139. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400+ CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR
    2 75 YR
    3 55 YR
    4 53 YR