BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 1060043 · Received June 12, 2008

    Report

    Report Number
    1628664-2008-00142
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A PATIENT GENERATED AN INITIAL AND REPEAT POTASSIUM RESULT OF >10 MMOL/L ON THE ARCHITECT C8000 ANALYZER. THIS RESULT WAS REPORTED TO THE PHYSICIAN. ADDITIONAL TESTING YIELDED A RESULT OF 4.55 MMOL/L AND THIS RESULT WAS CONFIRMED ON A BLOOD GAS ANALYZER. THE PATIENT WAS REFERRED TO THE ACCIDENT AND EMERGENCY DEPARTMENT IN THE HOSPITAL FOR ADDITIONAL TESTING. ANOTHER SAMPLE WAS OBTAINED YIELDING A POTASSIUM RESULT OF 4.3 MMOL/L USING THE SAME ARCHITECT ANALYZER THAT PRODUCED THE ORIGINAL HIGH RESULTS. THE PATIENT WAS NOT TREATED BASED ON THE FALSELY ELEVATED POTASSIUM RESULTS, AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR