BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSVIEW

    MDR report key: 473038 · Received July 18, 2003

    Report

    Report Number
    2031335-2003-00030
    Event Type
    Malfunction
    Date Received
    July 18, 2003
    Report Date
    June 23, 2003
    Manufacturer
    LXN CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT'S METER WOULD ONLY PROMPT AN ERROR 5 MESSAGE. NO SYMPTOMS REPORTED WHILE ATTEMPTING TO TEST. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    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