BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HITACHI 917 DISK

    MDR report key: 1110284 · Received August 14, 2008

    Report

    Report Number
    1823260-2007-05247
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    May 30, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATES THEY ARE HAVING ISE PROBLEMS AND GAVE THE FOLLOWING EXAMPLES OF DISCREPANT SODIUM RESULTS. SAMPLE 1: INITIAL SODIUM 126 MEQ/L, REPEATED AS 138 MEQ/L. SAMPLE 2: INITIAL 122MEQ/L, REPEATED AS 133 MEQ/L. SAMPLE 3: INITIAL 118 MEQ/L, REPEATED AS 132 MEQ/L. SAMPLE 4: INITIAL 124 MEQ/L, REPEATED AS 121 AND 133 MEQ/L. SAMPLE 5: INITIAL 130 MEQ/L, REPEATED AS 136 MEQ/L. THE AFFECTED PTS WERE NOT TREATED BASED ON THE INCORRECT VALUES. THE ACCOUNT REPAIRED THE INSTRUMENT BY REPLACING THE SAMPLE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HITACHI 917 DISK CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1