BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER 4000

    MDR report key: 2123606 · Received June 10, 2011

    Report

    Report Number
    1217183-2011-00011
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    PMA / PMN Number
    K093623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE AVAILABLE GEM PREMIER 4000 CARTRIDGE DATA SHOWED A TOTAL OF 174 SAMPLES WERE ANALYZED WITH THIS CARTRIDGE WHEN THE DATA WAS COPIED. THE CARTRIDGE WAS STILL IN USE AT 144 HOURS. TWO LEVELS OF CVP WERE ANALYZED AND PASSED FOR ALL ANALYTES THE FIRST TIME. THERE WERE NO DISABLED SENSORS. HOWEVER,THE SLOPES WERE NOISY AND THE B DRIFTS WERE LARGER THAN EXPECTED. RECALL: A RECALL HAS BEEN INITIATED TO NOTIFY THE FIELD REGARDING THE ISSUE WITH K+ REPORTING ON THE GEM PREMIER 4000. THIS RECALL ACTION WAS SUBMITTED AND WILL BE TRACKED THROUGH (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE POTASSIUM RESULTS ON THEIR GEM PREMIER 4000 WERE NOT CORRELATING WELL WITH A LAB REFERENCE DEVICE (ABBOTT ARCHITECT). EXAMPLE POTASSIUM RESULTS FROM SAMPLES RUN ON (B)(6) 2011, SHOWED THE FOLLOWING DIFFERENCES BETWEEN THE GEM PREMIER 4000 AND THE REFERENCE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1