BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE INDIRECT NA+ FOR GEN.2

    MDR report key: 2071563 · Received April 28, 2011

    Report

    Report Number
    1823260-2011-02296
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM, POTASSIUM AND CHLORIDE RESULTS FOR FIVE PATIENT SAMPLES FROM THE MODULAR CORE ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE SODIUM RESULT FOR ONE PATIENT SAMPLE WAS DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULT WAS 130 MEQ/L AND THE REPEAT RESULT WAS 141 MEQ/L. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE FOUND A SALT BRIDGE ON THE DILUENT GLASS BARREL AND CLEANED THE SALT BRIDGE. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION AND QUALITY CONTROL WITH RESULTS WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISE INDIRECT NA+ FOR GEN.2 ELECTRODE, ION SPECIFIC, SODIUM JGS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1