BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSVIEW METER

    MDR report key: 443784 · Received February 12, 2003

    Report

    Report Number
    2031335-2003-00009
    Event Type
    Malfunction
    Date Received
    February 12, 2003
    Report Date
    January 24, 2003
    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 THEIR EXPRESSVIEW METER WOULD ONLY PROMPT AN ERROR 5 MESSAGE. NO SYMPTOMS OR ADVERSE EVENTS REPORTED. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN