BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VIEW

    MDR report key: 436495 · Received January 2, 2003

    Report

    Report Number
    2031335-2002-00036
    Event Type
    Malfunction
    Date Received
    January 2, 2003
    Report Date
    December 12, 2002
    Manufacturer
    LXN CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED ERROR 5 WHEN TURNING ON THE METER AFTER A TEST STRIP WAS INSERTED. THE METER'S OPTIC AREA AND PLATFORM WERE CLEANED AND DRIED. THE PT THEN REPORTED THAT THE METER WOULD NOT TURN ON. THIS ISSUE WAS NOT RESOLVED. SERIAL NUMBER OF THIS METER WAS NOT PROVIDED.

    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