BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSVIEW

    MDR report key: 443782 · Received February 12, 2003

    Report

    Report Number
    2031335-2003-00010
    Event Type
    Malfunction
    Date Received
    February 12, 2003
    Report Date
    January 27, 2003
    Manufacturer
    LXN CORP.
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED LXN ALLEGING PT WAS UNABLE TO TEST ON THEIR EXPRESSVIEW METER. PT STATED THAT PT WAS UNABLE TO TEST DUE TO THE MESSAGE "CODE 847". THE "BLINKING TEST STRIP" ICON WOULD NOT APPEAR, WHICH PREVENTED THE CUSTOMER FROM PERFORMING A BLOOD TEST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN