BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM PREMIER 4000

    MDR report key: 1244384 · Received November 20, 2008

    Report

    Report Number
    1217183-2008-00004
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 20, 2008
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    PMA / PMN Number
    K061974
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL IL REVIEW OF THE RETURNED CARTRIDGE FILES FROM THE CUSTOMER'S GEM PREMIER 4000 INSTRUMENT INDICATED THAT A SAMPLE WAS ABORTED BY THE INSTRUMENT DUE TO AIR BEING DETECTED WITHIN THE SAMPLE, AND THEREFORE, THE SAMPLE WAS NOT RECORDED IN THE INSTRUMENT DATABASE. HOWEVER, THE SAMPLE RESULTS WERE STILL SENT TO THE LIS AND WERE PRINTED OUT. THIS ISSUE WAS IDENTIFIED AS A SOFTWARE DEFECT. IL IS FURTHER INVESTIGATING THIS INCIDENT AND EVALUATING THE ASSOCIATED RISK. BASED ON THE OUTCOME OF THE RISK ASSESSMENT, IL WILL TAKE THE NECESSARY REGULATORY ACTIONS AS APPROPRIATE.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED INDICATING CONCERN ABOUT THE FACT THAT THEY WERE UNABLE TO VIEW SAMPLE RESULTS IN THE GEM 4000 INSTRUMENT, ALTHOUGH THEY OBTAINED A PRINTED COPY OF THE PT SAMPLE REPORT. THE CUSTOMER ALSO STATED THAT THE INSTRUMENT GAVE AN "AIR IN THE SAMPLE MESSAGE". THERE WAS NO ADVERSE EVENT OR CHANGE IN PATIENT TREATMENT BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM PREMIER 4000 BLOOD GAS, ELECTROLYTE , CO-OX SYSTEM CHL INSTRUMENTATION LABORATORY CO. 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1