BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IL GEM PREMIER 3000 BLOOD GAS ANALYZER WITH IONIZED

    MDR report key: 844287 · Received April 30, 2007

    Report

    Report Number
    MW1042747
    Event Type
    Injury
    Date Received
    April 30, 2007
    Date of Event
    January 1, 2007
    Report Date
    April 30, 2007
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SINCE OUR STARTING TO USE OF THE IL GEM 3000 SYSTEM (FOR ABOUT ONE YEAR), WE HAVE NOTICED HIGH IONIZED CALCIUM VALUES WHENEVER A NEW REAGENT CARTRIDGE IS PLACED INTO SERVICE. THESE HIGH VALUES ARE NOTED WITH BOTH QUALITY CONTROL SPECIMENS AND PATIENT SPECIMENS. IF THESE HIGHER SPECIMENS ARE RUN ON THE OTHER IL GEM 3000 SYSTEM (OLDER REAGENT CARTRIDGE), THE VALUES FALL TO THE EXPECTED VALUE. THE DURATION OF THE ERRONEOUSLY HIGH VALUES IS QUITE SHORT AND PROBABLY CAN BE ASCERTAINED BY THE ANALYSIS OF QUALITY CONTROL SPECIMENS. THE SIZE OF THE POSITIVE BIAS IS ABOUT 0.08 AT CONCENTRATIONS OF 0.8 AND 1.25 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IL GEM PREMIER 3000 BLOOD GAS ANALYZER WITH IONIZED * CHL INSTRUMENTATION LABORATORY * *
    2 IL GEM PREMIER 3000 BLOOD GAS ANALYZER WITH IONIZED * CHL * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability