BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM PREMIER 4000

    MDR report key: 1491800 · Received October 1, 2009

    Report

    Report Number
    1217183-2009-00002
    Event Type
    Death
    Date Received
    October 1, 2009
    Date of Event
    September 3, 2009
    Report Date
    October 1, 2009
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    PMA / PMN Number
    K061974
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED TO REVIEW THE CARTRIDGE DATA FROM THE THREE GEM PREMIER 4000 INSTRUMENTS (1 ER UNIT AND 2 LAB UNITS) IN USE AT THE FACILITY. FOLLOWING ARE THE MAIN POINTS FROM THIS INVESTIGATION: ALL CARTRIDGE SENSORS WERE WORKING WITHIN SPECIFICATIONS AND THERE WAS NO INDICATION OF A MALFUNCTION. THERE WAS A DIFFERENCE IN SAMPLE TYPES, E.G. SAMPLES RUN ON THE GEM 4000 WERE ARTERIAL FROM A SYRINGE, WHEREAS THE SAMPLES RUN ON THE COULTER AND VITROS INSTRUMENTS WERE VENOUS USING A VACUTAINER TUBE. CARTRIDGE DATA INDICATED THAT RESULTS FROM THE DIFFERENT DRAWS WERE CONSISTENT ACROSS THE GEM PREMIER 4000 INSTRUMENTS AS SHOWN. CONCLUSION: POSSIBLE PRE-ANALYTICAL SAMPLE HANDLING ISSUE. THE RESULTS FROM THE DIFFERENT DRAWS AGREE ACROSS THE THREE GEM PREMIER 4000 INSTRUMENTS AND THE CARTRIDGE DATA INDICATES NO MALFUNCTION. NO REMEDIAL ACTION INDICATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT IN THE EMERGENCY ROOM WAS CODED, AND HAD TWO SAMPLES DRAWN WITH QUESTIONABLE RESULTS ON THE GEM PREMIER 4000. THE CUSTOMER INDICATED THAT THESE SAMPLES WERE REPEATED ON TWO OTHER GEM PREMIER 4000 LOCATED IN THE LABORATORY AND THE RESULTS AGREED. A SAMPLE WAS DRAWN AT APPROXIMATELY THE SAME TIME AT 08:53 FOR THB AND ANALYZED ON THE COULTER WITH A RESULT OF 13.8, INDICATING A DISCREPANCY WITH THE GEM PREMIER 4000. AT 07:45, CHEMISTRY SAMPLES WERE ANALYZED ON THE VITROS UNIT IN THE LAB, REPORTING A POTASSIUM OF 4.4. THE CRITICALLY ILL PATIENT PASSED AWAY AND PER THE CUSTOMER, IT IS UNCLEAR IF ANY RESULTS WERE USED FOR PATIENT CARE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death