BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VIEW METER

    MDR report key: 423305 · Received October 16, 2002

    Report

    Report Number
    2031335-2002-00014
    Event Type
    Malfunction
    Date Received
    October 16, 2002
    Report Date
    October 14, 2002
    Manufacturer
    LXN CORPORATION
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED TO ALLEGE THEIR LXN METER WOULD ONLY PROMPT AN ERROR 5 MESSAGE. UNABLE TO RESOLVE ISSUE WITH TORUBLESHOOTING. THE CUSTOMER DID NOT REPORT AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS VIEW METER BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LXN CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN