BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER 4000

    MDR report key: 2140462 · Received June 27, 2011

    Report

    Report Number
    1217183-2011-00008
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CEM
    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 CUSTOMER'S CARTRIDGE DATA DISK SHOWED THAT THE CUSTOMER RAN A TOTAL OF 264 SAMPLES PRIOR TO REMOVING THE CARTRIDGE AT HOUR 140.48. IN THEIR INITIAL TESTING PRIOR TO CARTRIDGE USE, THE CVP LEVEL 2 (EXTERNAL CONTROL) FAILED ON MULTIPLE ANALYTES, INCLUDING K+. CVP LEVEL 2 PASSED FOR ALL ANALYTES ON THE SIXTH RUN. DURING THE CARTRIDGE USE LIFE, THE K+ SENSOR WAS NOISY WITH UNSTABLE SLOPES. HOWEVER, THE SENSOR WAS NOT DISABLED BY THE SOFTWARE. THE INVESTIGATION IS ON-GOING AND A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE POTASSIUM RESULTS ON THEIR GEM PREMIER 4000 WERE NOT CORRELATING WELL WITH A REFERENCE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1