BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 MODULE CORE WITH ISE600

    MDR report key: 1761040 · Received July 19, 2007

    Report

    Report Number
    1823260-2007-06285
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    June 27, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING ERRATIC SODIUM RESULTS. THE FOLLOWING EXAMPLES WERE PROVIDED: INITIAL RESULT 128 MEQ/L, REPEAT 135 MEQ/L. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCIES.

    Description of Event or Problem · 2

    USER EXPERIENCING ERRATIC SODIUM RESULTS. THE FOLLOWING EXAMPLES WERE PROVIDED: INITIAL RESULT 128 MEQ/L, REPEAT 134 MEQ/L. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCIES.

    Description of Event or Problem · 3

    USER EXPERIENCING ERRATIC SODIUM RESULTS. THE FOLLOWING EXAMPLES WERE PROVIDED: INITIAL RESULT 123 MEQ/L, REPEAT 130 MEQ/L. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCIES.

    Description of Event or Problem · 4

    USER EXPERIENCING ERRATIC SODIUM RESULTS. THE FOLLOWING EXAMPLES WERE PROVIDED: INITIAL RESULT 129 MEQ/L, REPEAT 135 MEQ/L. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCIES.

    Description of Event or Problem · 5

    USER EXPERIENCING ERRATIC SODIUM RESULTS. THE FOLLOWING EXAMPLES WERE PROVIDED: INITIAL RESULT 133 MEQ/L, REPEAT 139 MEQ/L. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 MODULE CORE WITH ISE600 CLINICAL CHEMISTRY ANALYZER - JJE JGS ROCHE DIAGNOSTICS MODULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA
    2 NA
    3 NA
    4 NA
    5 NA