BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE SODIUM ELECTRODE

    MDR report key: 2180298 · Received July 27, 2011

    Report

    Report Number
    1823260-2011-04037
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K963627
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAS BEEN RECEIVING ONGOING QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS ON THEIR COBAS C111 (SERIAL NUMBER (B)(4)). THE CUSTOMER PROVIDED DATA FOR FIVE PATIENTS, OF WHICH THERE WAS ONE DISCREPANT RESULT REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S INITIAL SODIUM RESULT WAS 132 MMOL/L. ON (B)(6) 2011, SAMPLE WAS REPEATED AT A SISTER LABORATORY ON A C501 ANALYZER. THE REPEAT RESULT WAS 141 MMOL/L. THE CUSTOMER BELIEVED THE REPEAT RESULT WAS THE CORRECT RESULT. THERE WERE NO ADVERSE AFFECTS TO THE PATIENTS AS A RESULT OF THIS EVENT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE OF THIS EVENT WAS THE ELECTRODE BEING TOO CLEAN. HE HAD THE CUSTOMER PERFORM A SECOND ACTIVATION AFTER THE MORNING ISE SERVICE ACTION AND THEN PERFORM AN ADDITIONAL ISE ACTIVATION AT NOON. HE RECOMMENDED THEY PERFORM THE ADDITIONAL ACTIVATIONS EVERYDAY. VERIFIED THAT BY DOING THE ADDITIONAL ACTIVATIONS, THE SODIUM QUALITY CONTROL RESULTS MATCHED THE LABORATORY'S MEAN SODIUM QUALITY CONTROL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISE SODIUM ELECTRODE ELECTRODE, ION SPECIFIC, SODIUM JGS ROCHE DIAGNOSTICS NA 21504821

    Patients

    Seq Age Sex Outcome Treatment
    1