BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSVIEW

    MDR report key: 440914 · Received January 28, 2003

    Report

    Report Number
    2031335-2003-00008
    Event Type
    Malfunction
    Date Received
    January 28, 2003
    Report Date
    January 22, 2003
    Manufacturer
    LXN CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT'S METER WOULD NOT RECOGNIZE THE BLOOD SAMPLE. PT WAS WALKED THROUGH A CONTROL SOLUTION TEST, BUT THE METER WOULD NOT RECOGNIZE THE CONTROL SOLUTION SAMPLE. THIS ISSUE WAS NOT RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN