BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSVIEW

    MDR report key: 478348 · Received August 12, 2003

    Report

    Report Number
    2031335-2003-00033
    Event Type
    Malfunction
    Date Received
    August 12, 2003
    Report Date
    July 23, 2003
    Manufacturer
    LXN CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED LXN ALLEGING A "PC" MESSAGE WAS FROZEN ON THE DISPLAY. NO SYMPTOMS REPORTED WHILE ATTEMPTING TO TEST. THE ISSUE WAS UNRESOLVED WITH TROUBLESHOOTING. NO FURTHER INFORMATION HAS BEEN REPORTED.

    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