BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCHARGE

    MDR report key: 482853 · Received September 3, 2003

    Report

    Report Number
    2031335-2003-00035
    Event Type
    Malfunction
    Date Received
    September 3, 2003
    Report Date
    August 21, 2003
    Manufacturer
    LXN CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED ALLEGING THE METER WOULD ONLY PROMPT AN ERROR 5 MESSAGE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN