BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 311

    MDR report key: 3753013 · Received April 16, 2014

    Report

    Report Number
    1823260-2014-02731
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    April 5, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT WAS REQUESTED BUT NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE ISSUE WAS MOST LIKELY CAUSED BY CALIBRATION ERRORS DUE TO AN OPERATOR HANDLING ISSUE. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM, CHLORIDE, AND POTASSIUM RESULTS ON THEIR C311 ANALYZER. THE CUSTOMER STATED THERE WERE ABOUT EIGHT PATIENTS INVOLVED IN THIS EVENT, BUT ONLY PROVIDED DATA FOR THREE PATIENTS WITH DISCREPANT SODIUM AND CHLORIDE RESULTS. THE CUSTOMER STATED THE DISCREPANT RESULTS WERE REPORTED TO THE PHYSICIAN. THE PHYSICIAN DID NOT BELIEVE THE RESULTS AND REQUESTED THAT ALL THE SAMPLES BE SENT TO ANOTHER LABORATORY FOR REPEAT TESTING. THE FIRST PATIENT'S INITIAL SODIUM RESULT WAS 125 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. THE FIRST PATIENT'S INITIAL CHLORIDE RESULT WAS 90 MMOL/L. THE REPEAT RESULT WAS 100 MMOL/L. THE SECOND PATIENT, A 43 YEAR OLD MALE, HAD AN INITIAL SODIUM RESULT OF 122 MMOL/L. THE REPEAT RESULT WAS 135 MMOL/L. THE SECOND PATIENT'S INITIAL CHLORIDE RESULT WAS 90 MMOL/L. THE REPEAT RESULT WAS 100 MMOL/L. THE THIRD PATIENT, A 55 YEAR OLD FEMALE, HAD AN INITIAL SODIUM RESULT OF 124 MMOL/L. THE REPEAT RESULT WAS 138 MMOL/L. THE THIRD PATIENT'S INITIAL CHLORIDE RESULT WAS 89 MMOL/L. THE REPEAT RESULT WAS 99 MMOL/L. THE PHYSICIAN DID NOT GIVE ANY MEDICATIONS OR TREATMENTS BASED ON THE DISCREPANT RESULTS. THERE WERE NO ADVERSE EVENTS. THE SODIUM ELECTRODE LOT NUMBER WAS 170364. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE CHLORIDE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. IT WAS NOTED THE COMPENSATOR VALUES IN THE ANALYZER WERE FOR A DIFFERENT LOT THAN THE CUSTOMER WAS USING. THE COMPENSATOR VALUES WERE UPDATED, THE ANALYZER WAS CALIBRATED, AND QUALITY CONTROL WAS PERFORMED. THE QUALITY CONTROL RESULTS WERE WITHIN RANGE. IT WAS NOTED THE CUSTOMER REPLACED THE ISE INTERNAL STANDARD BOTTLE AFTER THE FIRST QUALITY CONTROL OF THE DAY, BUT DID NOT PERFORM CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232888 COBAS 311 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 016 YR