BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEROSET ANALYZER

    MDR report key: 579776 · Received December 14, 2004

    Report

    Report Number
    1628664-2004-00044
    Event Type
    Other
    Date Received
    December 14, 2004
    Date of Event
    November 17, 2004
    Report Date
    December 14, 2004
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PT SAMPLE GENERATED A POTASSIUM RESULT OF 6.2 MEQ/L ON THE AEROSET ANALYZER. THE RESULT WAS NOT REPORTED OUT OF THE LAB. THE SAMPLE REPEATED AT 3.9 MEQ/L ON ANOTHER AEROSET ANALYZER IN THE LAB. THE SAMPLE WAS REPETED AGAIN ON THE INITIAL AEROSET ANALYZER AND GENERATED A RESULT OF 3.7 MEQ/L. CONTROLS HAVE BEEN WITHIN SPECIFICATIONS. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other AEROSET/C8000 ICT MODULE LOT#: AA40705010.