BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 287582 · Received July 27, 2000

    Report

    Report Number
    1628664-2000-00047
    Event Type
    Other
    Date Received
    July 27, 2000
    Report Date
    July 26, 2000
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED TOP LID OF AXSYM FAILED TO STAY UP. CONTACT DATE WAS 6/27/2000 THE WEEK PRIOR (NO DATE GIVEN) THE AXSYM LID FELL AND HIT OPERATOR IN THE HEAD. OPERATOR STATED THAT NO INJURY OCCURRED. CUSTOMER REFUSED TO GIVE ANY ADDITIONAL INFO. NO REPORT OF INJURY.

    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 NA