BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 289027 · Received August 4, 2000

    Report

    Report Number
    1628664-2000-00051
    Event Type
    Malfunction
    Date Received
    August 4, 2000
    Report Date
    August 2, 2000
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THEY RECEIVED LETTER LAST WEEK, INSTRUCTING TO CHECK GAS SPRINGS. WHILE CHECKING SPRINGS, TOP LID FELL AND HIT THE LEFT HAND ACROSS THE KNUCKLES. CUSTOMER WAS NOT INJURED AND DID NOT GO TO ER/HEALTH CLINIC. NO ADD'L INFO AVAILABLE. DATE OF INJURY NOT PROVIDED.

    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 NO INFO