BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 383379 · Received March 13, 2002

    Report

    Report Number
    1628664-2002-00007
    Event Type
    Malfunction
    Date Received
    March 13, 2002
    Date of Event
    February 12, 2002
    Report Date
    March 13, 2002
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE AXSYM PROCESSING COVER FELL AND THE LATCH ON THE COVER HIT THEIR HAND ON THE WAY DOWN. THE CUSTOMER STATES THAT THEIR HAND IS ALRIGHT AND THAT NO MEDICAL ATTENTION WAS SOUGHT. NO SERIOUS INJURY WAS REPORTED.

    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 UNKNOWN