BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 218487 · Received April 8, 1999

    Report

    Report Number
    1628664-1999-00017
    Event Type
    Malfunction
    Date Received
    April 8, 1999
    Date of Event
    March 8, 1999
    Report Date
    April 7, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER OBTAINED AN ETHANOL RESULT FROM ER PATIENT OF 0.0 MG/DL. THE RESULT WAS QUESTIONED BY PHYSICIAN, A REPEAT WAS PERFORMED WITH A RESULT OF >300MG/DL. THE FOLLOWING MORNING A SECOND SAMPLE WAS ORDERED WITH A RESULT OF 0.00 MG/DL SAMPLE WAS REPEATED WITH A RESULT OF 299.19MG/DL BEFORE RELEASING OUT OF LAB. PATIENT CARE WAS NOT AFFECTED BY INITIAL RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR AXSYM ETHANOL REAGENT LIST NUMBER 3B32-20. LOT| LOT NUMBER 45659Q100 EXP. 16 MAY 1999.