BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER 4000

    MDR report key: 2123585 · Received June 10, 2011

    Report

    Report Number
    1217183-2011-00013
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 12, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE GEM PREMIER 4000 CARTRIDGE DATA SHOWED THAT 175 SAMPLES WERE RUN. THERE WERE NO DISABLED SENSORS. DATA SHOWS K+ SENSOR SLOPES WERE WITHIN RANGE. HOWEVER, THE SLOPES WERE NOISY WITH AN UNSTABLE BASELINE. NEITHER COMPARISON DATA NOR ANY OTHER INFORMATION ABOUT THE SAMPLES IN QUESTION WAS AVAILABLE TO INVESTIGATE FURTHER. 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 INACCURATE RESULTS FROM THE POTASSIUM PARAMETER ON THEIR GEM PREMIER 4000. K+ RESULTS FROM THE GEM PREMIER 4000 WERE TOO LOW WHEN COMPARED TO A REFERENCE ANALYZER. BIASES EXCEED THE INSTRUMENT'S TOTAL ALLOWABLE ERROR CLAIM OF +/- 0.5 MMOL/L.

    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