BEUDAMED
    FDA Adverse Event Other Summary report: N

    GEM PREMIER 3000

    MDR report key: 1011986 · Received March 11, 2008

    Report

    Report Number
    1217183-2008-00001
    Event Type
    Other
    Date Received
    March 11, 2008
    Date of Event
    January 17, 2008
    Report Date
    March 11, 2008
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    PMA / PMN Number
    K052121
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL IL REVIEW OF THE RETURNED CARTRIDGE FILES FROM THE CUSTOMER'S GEM PREMIER 3000 INSTRUMENT INDICATES THAT ALL FOUR LEVELS OF IL CVP PASSED FOR ALL ANALYTES AND THAT THERE WERE NO SENSOR DRIFT OR SLOPE FAILURES RECORDED. THE PT PRINTOUTS SHOW TWO SETS OF RESULTS ON THE SAME PT TREATED WITH 100% FI02 WITH A MARKED DIFFERENCE IN THE PO2 VALUES. THE QUESTIONABLE DIFFERENCE IN THE PO2 VALUES APPEARED WHEN THE HCT RESULT FOR THAT SAME SAMPLE REPORTED AS "INCALCULABLE". THIS COULD INDICATE THAT THE AIR FOLLOWING THE SAMPLE IS LOCATED OVER THE HCT SENSOR THUS CAUSING THE INCALCULABLE RESULT AND ALSO AFFECTING THE PO2 VALUE IN THIS SAMPLE. A SECOND POSSIBLE CAUSE OF THE PO2 TO READ LOW IS USER MISHANDLING OF THE SAMPLE. THE INCIDENT IS STILL UNDER ACTIVE INVESTIGATION. ANY NECESSARY REMEDIAL ACTIONS WILL BE DEFINED BASED ON THE INVESTIGATION CONCLUSION AND ASSESSED RISK.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED INDICATING CONCERN ABOUT PT REPEATABILITY FOR HCT AND PO2 ON THEIR GEM PREMIER 3000 INSTRUMENT. THEY STATED THAT THREE SAMPLES SEEMED HIGH ON HCT AND THE PO2 SHIFTED ON REPEAT ANALYSIS. THEY ALSO STATED THAT SEVERAL HCT RESULTS WERE INCALCULABLE. THERE WAS NO ADVERSE EVENT OR CHANGE IN PT TREATMENT BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM PREMIER 3000 BLOOD GAS ANALYZER CHL INSTRUMENTATION LABORATORY CO. 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1