BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN CHARGE BLOOD GLUCOSE MONITOR SYSTEM

    MDR report key: 414259 · Received August 29, 2002

    Report

    Report Number
    2031335-2002-00007
    Event Type
    Death
    Date Received
    August 29, 2002
    Date of Event
    July 4, 2002
    Manufacturer
    LXN CORP.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 8/2002, THE SPOUSE OF A DIABETIC PT CALLED THE MFR STATING THE PT DIED IN 2002 AND THE SPOUSE WANTED TO KNOW IF THE PT'S IN CHARGE METER WAS INACCURATE. SOMETIME BEFORE THAT DAY, THE PT WAS FEELING NERVOUSNESS AND BREAKING INTO A SWEAT. THE PT PERFORMED A GLUCOSE TEST USING THEIR IN CHARGE METER AND RECEIVED A TEST RESULT OF 35 MG/DL. THE PT TOOK HUMALOG, WENT INTO A SEIZURE AND WAS THEN RUSHED TO THE HOSPITAL EMERGENCY ROOM. APPROX 30 MINUTES AFTER TESTING WITH THEIR IN CHARGE METER ANOTHER GLUCOSE TEST WAS PERFORMED USING A DIFFERENT DEVICE. THE PT'S GLUCOSE LEVEL WAS 489-500 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN CHARGE BLOOD GLUCOSE MONITOR SYSTEM GLUCOSE MONITOR/TEST STRIPS CGA LXN CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death