BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 3000 BLOOD GAS ANALYZER

    MDR report key: 1282164 · Received January 6, 2009

    Report

    Report Number
    MW5009543
    Event Type
    Malfunction
    Date Received
    January 6, 2009
    Date of Event
    January 1, 2009
    Report Date
    January 6, 2009
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE IL GEM 3000 BLOOD GAS SYSTEM PRODUCES A SERIES OF CLINICALLY INCORRECT IONIZED CALCIUMS WITH NEW CARTRIDGE REPLACEMENTS. USING QUALITY CONTROL SAMPLES, THE HIGH CONTROL SHIFTS FROM AVERAGE OF 1.5 MMOL/L TO 1.57 TO 1.65 MMOL/L; THE NORMAL CONTROL SHIFTS FROM 1.14 MMOL/L TO UP TO 1.20 MMOL/L AND THE LOW CONTROL FROM 0.52 MMOL/L TO 0.57 MMOL/L. THESE VARIATIONS ARE ALSO EVIDENT IN PT SAMPLES THAT ARE RUN AT THE SAME TIME. WE HAVE MITIGATED SOME OF THESE SHORT TERM INCREASES BY RUNNING CONTROLS AND PTS WITH EACH NEW CARTRIDGE REPLACEMENT. WE INFORMED THE COMPANY OF THIS ISSUE WELL OVER A YEAR AGO AND THEY HAVE NOT MADE ANY RECOMMENDATIONS TO REDUCE THESES ERRORS. THE IL CORPORATION HAS SUPPORTED CONSULTANTS WHO CLAIM THAT ANALYSIS OF QC IS NOT NECESSARY FOR THIS DEVICE. IF WE DID NOT RUN QC, WE WOULD NOT HAVE BEEN ABLE TO DOCUMENT THIS DEFICIENCY. SOME OF THESE OUTLIERS ARE MEDICALLY INCORRECT AND CERTAINLY RESULTS IN INCREASED TESTING. I SUSPECT THAT SOME OF THESE INCORRECT RESULTS ARE FOLLOWED BY UNNECESSARY THERAPY. DATES OF USE: 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM 3000 BLOOD GAS ANALYZER GEM 3000 IONIZED CALCIUM CHL INSTRUMENTATION LABORATORY GEM 3000

    Patients

    Seq Age Sex Outcome Treatment
    1