BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE SODIUM ELECTRODE

    MDR report key: 1860662 · Received October 7, 2010

    Report

    Report Number
    1823260-2010-05984
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 16, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    JGS
    PMA / PMN Number
    K071211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE CUSTOMER IS NOT WILLING TO PROVIDE FURTHER INFORMATION FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE FIELD APPLICATION SPECIALIST REPORTED THE USER RECEIVED QUESTIONABLE SODIUM RESULTS FOR ONE PATIENT SAMPLE FROM THE INTEGRA 800 SERIAL NUMBER (B)(4). THE ORIGINAL RESULT WAS 128 MMOL/L. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER WITH RESULTS OF 133, 131, 127, 127, 126, AND 127 MMOL/L. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER IN A SAMPLE CUP WITH RESULTS OF 132, 127, 127, 127 AND 127 MMOL/L. THE SAMPLE WAS THEN REPEATED ON INTEGRA 800 SERIAL NUMBER (B)(4) WITH RESULTS OF 132, 132, 132, 132 AND 132 MMOL/L. THE PATIENT WAS NOT TREATED BASED ON THE ORIGINAL RESULT AS IT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE RESULT OF 132 MMOL/L FROM ANALYZER (B)(4) WAS REPORTED OUTSIDE THE LABORATORY. 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 THE MIX TOWER AND CHECKED THE ISE OPERATION, HE VERIFIED THE ANALYZER OPERATION BY RUNNING ISE PERFORMANCE CHECKS, CALIBRATION, QUALITY CONTROL AND A PRECISION CHECK. 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, DEBRIS, HEMOLOSIS, LIPEMIA AND ICTERUS. PRECISION TESTING, CALIBRATION AND QUALITY CONTROL WERE ALL ACCEPTABLE AND THE ANALYZER WAS OPERATING AS EXPECTED AND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THAT PATIENT UNDERWENT AN AXIAL LUMBAR INTERBODY FUSION. SOMETIME POST-OP THE PATIENT HAD PSEUDOARTHROSIS AT L5-S1 AND UNDERWENT A REVISION SURGERY, ANTERIOR INTERBODY FUSION WITH PLATING. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISE SODIUM ELECTRODE ELECTRODE, ION SPECIFIC, SODIUM JGS ROCHE DIAGNOSTICS CORPORATION 21594532

    Patients

    Seq Age Sex Outcome Treatment
    1