BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1030684 · Received April 15, 2008

    Report

    Report Number
    1628664-2008-00089
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ABBOTT MANUFACTURING , INC
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    Reporter Occupation
    UNKNOWN

    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 PT SAMPLE WAS TESTED ON THE AXSYM PHENOBARBITAL ASSAY YIELDING A RESULT OF 0.00 UG/ML. TWO OUT OF THREE CONTROLS WERE WITHIN RANGE. THE MEDIUM CONTROL WAS OUT OF RANGE HIGH. THE TECHNICIAN SUSPECTED THAT THE RESULT GENERATED WAS INCORRECT AND THE SAMPLE WAS RETESTED YIELDING A RESULT OF 20.10 UG/ML. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING , INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM PHENOBARBITAL REAGENT| LOT # 57245Q100