BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 275181 · Received April 20, 2000

    Report

    Report Number
    1628664-2000-00023
    Event Type
    Malfunction
    Date Received
    April 20, 2000
    Date of Event
    March 18, 2000
    Report Date
    April 17, 2000
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON 3/18/2000, THE TOP COVER OF AXSYM FELL AND HIT THE CUSTOMER ON THE HEAD. HEAD WAS SORE, BUT NOT CUT. NO MEDICAL ATTENTION NECESSARY.

    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 42 YR