BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEROSET ANALYZER

    MDR report key: 731786 · Received June 26, 2006

    Report

    Report Number
    1628664-2006-00062
    Event Type
    Other
    Date Received
    June 26, 2006
    Date of Event
    March 6, 2006
    Report Date
    April 26, 2006
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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

    A PATIENT SAMPLE GENERATED A POTASSIUM RESULT OF 2.5 MMOL/L USING AN AEORSET ANALYZER (ANALYZER #1). THE SAMPLE WAS THEN REPEATED YIELDING A POTASSIUM RESULT OF 3.5 MMOL/L USING ANOTHER AEROSET ANALYZER (ANALYZER #2). THE 3.5 MMOL/L RESULT WAS REPORTED. A LABORATORY TECHNICIAN DISCOVERED THE DIFFERENCE BETWEEN THE TWO RESULTS AND REPEATED THE SAMPLE USING ANALYZER #2 OBTAINING A 2.6 MMOL/L RESULT. THE SAMPLE WAS THEN REPEATED USING AN ALTERNATE METHOD (OMNI) OBTAINING A RESULT OF 2.4 MMOL/L. A CORRECTED REPORT WAS SENT OUT WITH A 2.6 MMOL/L RESULT AND THE DOCTOR WAS INFORMED WITH NO IMPACT TO PATIENT 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 ICT MODULE LOT#: AA50819045 , LIST 9D28-02