BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1083612 · Received July 29, 2008

    Report

    Report Number
    1628664-2008-00182
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    THE CUSTOMER STATES THAT THE AXSYM VANCOMYCIN II ASSAY GENERATED THE FOLLOWING RESULTS ON ONE PT SAMPLE. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. FIELD SERVICE WAS REQUESTED TO INSPECT AND SERVICE THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LOT # UNKNOWN| AXSYM VANCOMYCIN II REAGENT