BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VIEW

    MDR report key: 482843 · Received September 3, 2003

    Report

    Report Number
    2031335-2003-00034
    Event Type
    Malfunction
    Date Received
    September 3, 2003
    Report Date
    August 13, 2003
    Manufacturer
    LXN CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT ALLEGED "PC" MESSAGE ON THE DISPLAY. NO SYMPTOMS REPORTED WHILE ATTEMPTING TO TEST. THE ISSUE WAS NOT RESOLVED WITH TROUBLE SHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS VIEW BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LXN CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN