BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VIEW

    MDR report key: 443778 · Received February 12, 2003

    Report

    Report Number
    2031335-2003-00012
    Event Type
    Malfunction
    Date Received
    February 12, 2003
    Report Date
    February 5, 2003
    Manufacturer
    LXN CORP.
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED LXN ALLEGING THEIR METER WOULD NOT START THE COUNTDOWN, THEREFORE, WOULD NOT OBTAIN THEIR BLOOD GLUCOSE RESULT. PT DID NOT ALLEGE HARM OR ANY INJURY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN