BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER 4000

    MDR report key: 2123607 · Received June 10, 2011

    Report

    Report Number
    1217183-2011-00010
    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
    MZV
    PMA / PMN Number
    K093623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE AVAILABLE GEM PREMIER 4000 CARTRIDGE DATA SHOWED THAT 417 SAMPLES WERE ANALYZED. TWO LEVELS OF CVP WERE ANALYZED AND PASSED FOR ALL ANALYTES. THERE WERE NO DISABLED SENSORS. THE K+ SENSOR WAS NOISY WITH AN UNSTABLE BASELINE. PARTICULAR SAMPLE NUMBERS WERE NOT DEFINED, AND COMPARISON DATA WERE ONLY AVAILABLE FOR ONE SAMPLE OUTSIDE OF THE ALLOWABLE ERROR CLAIMS OF THE GEM PREMIER 4000 (+/- 0.5 MMOL/L) AS FOLLOWS: GEM PREMIER 4000 RESULT: 4.0 MMOL/L. VISTA RESULT: 4.6 MMOL/L. 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 (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. ACCORDING TO THEM, ONE OF THEIR STUDIES INDICATED A CONSISTENT NEGATIVE BIAS WITH GEM PREMIER 4000 VERSUS THE VISTA, RANGING FROM -0.3 TO -0.9 MMOL/L DIFFERENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1