BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VIEW

    MDR report key: 436541 · Received January 2, 2003

    Report

    Report Number
    2031335-2002-00039
    Event Type
    Malfunction
    Date Received
    January 2, 2003
    Report Date
    December 20, 2002
    Manufacturer
    LXN CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ALLEGING THEIR METER HAD NO POWER, THEY ATTEMPTED TO PLACE A NEW BATTERY IN THE METER, BUT STILL NO POWER. NO SYMPTOMS REPORTED. NO ADVERSE EVENT REPORTED. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER HAS BEEN REPLACED.

    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