BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX3D

    MDR report key: 68541 · Received February 5, 1997

    Report

    Report Number
    2050012-1997-00002
    Event Type
    Malfunction
    Date Received
    February 5, 1997
    Date of Event
    January 21, 1997
    Report Date
    February 5, 1997
    Manufacturer
    BECKAMN INSTRUMENTS, INC.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN RUNNING A PT SAMPLE FOR GLUCOSE ON INSTRUMENT, A RESULT OF 85 MG/DL WAS OBTAINED AND REPORTED. THE PT HAD A PREVIOUS GLUCOSE OF 830 AND THIS RESULT WAS QUESTIONED PRIOR TO ANY TREATMENT. THE SAME SAMPLE WAS RE-RUN SEVERAL TIMES AND RECOVERED GLUCOSE VALUES OF 823-582.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX3D CLINICAL CHEMISTRY ANALYZER JJC BECKAMN INSTRUMENTS, INC. CX3 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other