BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER 4000

    MDR report key: 2123586 · Received June 10, 2011

    Report

    Report Number
    1217183-2011-00012
    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
    CIG
    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: THE GEM PREMIER 4000 CARTRIDGE DATA WAS RECEIVED FROM THE CUSTOMER BUT THE SAMPLES IN QUESTION WERE NOT INCLUDED. CLARIFICATION REQUESTED FROM THE CUSTOMER. 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 THE LOCAL (B)(4) FDA DISTRICT OFFICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE POTASSIUM RESULTS ON THEIR GEM PREMIER 4000 WERE ERRONEOUS, WITH LARGE DIFFERENCES VERSUS THEIR LAB DEVICE. ON POTASSIUM RESULT IN QUESTION WAS 4.0 MMOL/L ON THE GEM PREMIER 4000 AND THE LAB RESULT WAS 4.6 MMOL/L.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1