BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE SODIUM ELECTRODE

    MDR report key: 1864565 · Received October 12, 2010

    Report

    Report Number
    1823260-2010-06063
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 17, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K071211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE CUSTOMER WAS UNWILLING TO PROVIDE INFORMATION FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, RESISTANCE WAS ENCOUNTERED AND THE GUIDE WIRE COATING WAS "COMING OFF". THE 300CM KINETIX PLUS PTCA GUIDE WIRE WAS PLACED IN AN UNKNOWN VESSEL. AN 8MM X 3.00MM QUANTUM APEX BALLOON CATHETER WAS ADVANCED OVER THE WIRE. THE PHYSICIAN NOTED A "TACKY FEEL" WHILE REMOVING THE APEX BALLOON CATHETER FROM THE KINETIX WIRE; HOWEVER, THE BALLOON WAS ABLE TO BE REMOVED FROM THE WIRE. IT WAS FURTHER NOTED THAT THE COATING OF THE GUIDE WIRE MAY HAVE PEELED OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE SODIUM RESULTS FOR ONE PATIENT SAMPLE ON THE INTEGRA 800 ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULT FOR SODIUM GAVE 133 MMOL/L. THE SAMPLE WAS REPEATED TWICE GIVING 139 AND 140 MMOL/L. THERE WERE NO ERRONEOUS RESULTS REPORTED AND PATIENT WAS NOT AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A DEFECTIVE SODIUM ELECTRODE AND FOUND A "BUMP" OF MATERIAL NEXT TO THE FLOW PATH HOLE ON THE ELECTRODE. THIS BUMP LOOKED TO BE PLASTIC OR A GLUE OF SOME SORT. WHEN THE O-RING FROM THE ADJOINING ELECTRODE WOULD PRESS AGAINST THIS ELECTRODE, THE BUMP WOULD NOT CREATE A GOOD SEAL CAUSING LEAKAGE. HE REPLACED THE ELECTRODE AND RAN PERFORMANCE TESTS TO VERIFY ANALYZER PERFORMANCE. THE FIELD APPLICATION SPECIALIST COULD NOT DETERMINE A CAUSE. SHE VERIFIED THE CALIBRATION AND QUALITY CONTROL RESULTS AND EXAMINED THE SAMPLE. SHE FOUND THE SAMPLE WAS FREE OF FIBRIN AND DEBRIS. PRECISION TESTING, CALIBRATION AND QUALITY CONTROL WERE ALL ACCEPTABLE AND THE ANALYZER WAS OPERATING AS EXPECTED AND WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISE SODIUM ELECTRODE ELECTRODE, ION SPECIFIC, SODIUM JGS ROCHE DIAGNOSTICS 21500720

    Patients

    Seq Age Sex Outcome Treatment
    1