BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX7D

    MDR report key: 68117 · Received February 3, 1997

    Report

    Report Number
    2050012-1997-00001
    Event Type
    Malfunction
    Date Received
    February 3, 1997
    Date of Event
    January 13, 1997
    Report Date
    January 27, 1997
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN RUNNING A BARCODE LABELED SAMPLE ON A SYSTEM, THE BARCODE READER MISREAD THE BARCODE AND ASSIGNED THE RESULTS OF THE TESTING TO THE INCORRECT PT. THIS ERROR WAS IDENTIFIED IN THE LAB AND NO RESULTS WERE REPORTED. THE SAME SAMPLE TUBE WITH THE SAME BARCODE LABEL WAS SUBSEQUENTLY RE-RUN AND WAS CORRECTLY IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX7D CLINICAL CHEMISTRY ANALYZER S/W VER. 4.0/4.1 JJC BECKMAN INSTRUMENTS, INC. CX7 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other