BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEROSET ANALYZER

    MDR report key: 579873 · Received July 8, 2004

    Report

    Report Number
    1628664-2004-00024
    Event Type
    Other
    Date Received
    July 8, 2004
    Date of Event
    June 16, 2004
    Report Date
    July 7, 2004
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PT'S INITIAL AEROSET SODIUM ASSAY RESULT OF PT'S INITIAL AEROSET SODIUM ASSAY RESULT OF 181 MEQ/L REPEATED AT 143 MEQ/L. NO ADDITIONAL PT INFO IS AVAILABLE. CONTROLS WERE 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 AEROSET C8000 ICT MODULE.