BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VIEW

    MDR report key: 439146 · Received January 15, 2003

    Report

    Report Number
    2031335-2003-00005
    Event Type
    Malfunction
    Date Received
    January 15, 2003
    Report Date
    January 13, 2003
    Manufacturer
    LXN CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED THAT THEIR METER POWERED OFF PREMATURELY WHEN TURNED ON. THE PT HAD REPLACED THE BATTERY A WEEK AGO. WHILE TROUBLESHOOTING, IT WAS MADE SURE THAT THE BATTERY WAS SEATED PROPERLY. ISSUE WAS STILL NOT RESOLVED.

    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