BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1102166 · Received August 7, 2008

    Report

    Report Number
    1628664-2008-00192
    Event Type
    Other
    Date Received
    August 7, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: INVESTIGATION IS IN PROCESS, NO METHOD, RESULTS, OR CONCLUSION CAN BE DRAWN AT THIS TIME. 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 ACCOUNT STATED THE AXSYM SAMPLE PIPETTOR LEAKED FROM BETWEEN THE PROBE AND PROBE LINK TUBING AND APPEARED TO SHORT OUT THE PIPETTOR PARTS WHERE SMOKE CAME OUT. THE AXSYM ANALYZER IS POWERED OFF. SERVICE WAS REQUESTED FOR THE AXSYM ANALYZER. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA