BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE 9180

    MDR report key: 3849117 · Received June 4, 2014

    Report

    Report Number
    1823260-2014-04013
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 20, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFP
    PMA / PMN Number
    K961458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED DATA FOR THREE PATIENTS WITH QUESTIONABLE ION SELECTIVE ELECTRODE POTASSIUM RESULTS, OF WHICH TWO HAD DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE TESTED ON (B)(6) 2014. THE SAMPLES WERE REPEATED ON ANOTHER 9180 ANALYZER. THE FIRST PATIENT'S INITIAL POTASSIUM RESULT WAS 7.35 MMOL/L. THE REPEAT RESULT WAS 8.2 MMOL/L. THE SECOND PATIENT'S INITIAL POTASSIUM RESULT WAS 4.5 MMOL/L. THE REPEAT RESULT WAS 5.0 MMOL/L. INFORMATION ON WHETHER THE PATIENTS WERE ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE POTASSIUM ELECTRODE LOT NUMBER WAS 21522761. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE NAME WAS UPDATED.

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT NOTED THE CUSTOMER DID NOT RUN QUALITY CONTROL PRIOR TO TESTING THE SAMPLES. IT WAS NOTED THE SODIUM AND POTASSIUM HAD BEEN ON BOARD THE ANALYZER FOR OVER A YEAR AND WERE PASSED THEIR ON BOARD TIMES. QUALITY CONTROL VERIFICATION BY THE CUSTOMER SHOULD HAVE INFORMED THEM OF THE STATE OF THE ELECTRODES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE SODIUM ELECTRODE LOT NUMBER WAS 21522955.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED VERY LOW ION SELECTIVE ELECTRODE SODIUM AND POTASSIUM RESULTS ON THEIR ISE 9180 ANALYZER. THE CUSTOMER PROVIDED DATA FOR ONE DISCREPANT SODIUM RESULT THAT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S INITIAL SODIUM RESULT WAS 95 MMOL/L. THE REPEAT RESULT WAS 109 MMOL/L. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE SODIUM ELECTRODE LOT NUMBER WAS REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CHECKED AND CLEANED THE ELECTRODES, NEEDLE, AND WASH PORT. HE TESTED THE ELECTRODES AND FOUND VARIATIONS. HE PERFORMED CALIBRATION. HE RAN SAMPLES AND FOUND VARIATIONS IN THE SODIUM AND POTASSIUM RESULTS. IT WAS NOTED THE CUSTOMER WAS NOT PERFORMING QUALITY CONTROL ON THE ANALYZER TO CHECK THE PERFORMANCE OF THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327525 ISE 9180 BLOOD GAS ANALYZER JFP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 044 YR