BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN CHARGE BLOOD GLUCOSE MONITOR SYSTEM

    MDR report key: 407676 · Received July 26, 2002

    Report

    Report Number
    2031335-2002-00005
    Event Type
    Injury
    Date Received
    July 26, 2002
    Date of Event
    June 28, 2002
    Report Date
    July 26, 2002
    Manufacturer
    LXN CORP.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A DIABETIC PT COULD NOT GET A READING (TEST RESULT) FROM PT'S IN CHARGE METER. WHILE TESTING, THE METER SHUT ITSELF OFF BEFORE DISPLAYING THE TEST RESULT. THE PT WAS FEELING NAUSEATED, LIKE PT'S GLUCOSE LEVEL WAS HIGH. THE PT'S SPOUSE TOOK PT TO THE HOSP EMERGENCY ROOM WHEREUPON, THE PT'S GLUCOSE LEVEL WAS ASSESSED. PT'S GLUCOSE LEVEL WAS 533 MG/DL. WHILE IN THE HOSP EMERGENCY ROOM, THE PT WAS GIVEN AN IV TO LOWER PT'S BLOOD GLUCOSE LEVEL AND LATER RELEASED WITH THE INSTRUCTION TO CALL THE DR. NOTE: ALTHOUGH NOT RELATIVE TO THE REPORTED PROBLEM, THE STRIPS THE PT WAS USING TO PERFORM THE GLUCOSE TEST HAD EXPIRED WELL OVER A YEAR AGO. THE EXPIRATION DATE ON THE TEST STRIP VIAL WAS 05/2001.

    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 8012 0500735

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R