BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSVIEW

    MDR report key: 437994 · Received January 15, 2003

    Report

    Report Number
    2031335-2002-00033
    Event Type
    Malfunction
    Date Received
    January 15, 2003
    Report Date
    December 2, 2002
    Manufacturer
    LXN CORP.
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED ALLEGING THAT WHEN TESTING THEIR BLOOD SUGAR THE METER DOES NOT COUNT DOWN AFTER APPLYING THE BLOOD TO THE TEST STRIP. CUSTOMER STATED THERE IS A "G" SYMBOL ON THE DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN