BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER 4000

    MDR report key: 1081856 · Received July 18, 2008

    Report

    Report Number
    1217183-2008-00003
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    May 23, 2008
    Report Date
    July 18, 2008
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    PMA / PMN Number
    K061974
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERNAL INVESTIGATION OF THE GEM PREMIER 4000 CARTRIDGE DATA IDENTIFIED A SOFTWARE DEFECT THAT CAUSED THE ANALYZER TO RUN CONTINUOUS B CALIBRATIONS FOR FOUR DAYS, LEADING TO THE EVENTUAL PROCESS SOLUTION DETECTION FAILURE. DURING THE FOUR-DAY PERIOD, THE USER WAS ABLE TO RUN SAMPLES BECAUSE THE B CALIBRATIONS WERE INTERRUPTIBLE. THE TWENTIETH SAMPLE TRIGGERED THE SOFTWARE TO BREAK THE CONTINUOUS LOOP AND RUN A, C, AND D CALIBRATIONS. THERE WERE NO DRIFT ERRORS FOR SLOPE OR C AND D SOLUTIONS WHEN THE FULL CALIBRATION SCHEDULE RESUMED. IL IS FURTHER INVESTIGATING THIS INCIDENT AND EVALUATING THE ASSOCIATED RISK. BASED ON THE OUTCOME OF THE RISK ASSESSMENT, IL WILL TAKE THE NECESSARY REGULATORY ACTIONS AS APPROPRIATE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE GEM PREMIER 4000 CARTRIDGE FAILED DUE TO A PROCESS SOLUTION NOT DETECTED ERROR. DURING THE SUBSEQUENT COMPLAINT INVESTIGATION BY INSTRUMENTATION LABORATORY, WE IDENTIFIED THAT ALL CALIBRATIONS, EXCEPT B-CALIBRATIONS, WERE MISSING FOR FOUR DAYS. THERE WAS NO KNOWN ADVERSE EVENT TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM PREMIER 4000 BLOOD GAS, ELECTROLYTE, CO-OX SYSTEM CHL INSTRUMENTATION LABORATORY CO. 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1