BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESSVIEW BLOOD GLUCOSE MONITOR SYSTEM

    MDR report key: 405669 · Received July 9, 2002

    Report

    Report Number
    2031335-2002-00003
    Event Type
    Injury
    Date Received
    July 9, 2002
    Date of Event
    June 10, 2002
    Report Date
    July 9, 2002
    Manufacturer
    LXN CORP.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A DIABETIC RECEIVED LOW GLUCOSE VALUES OF 57, 70, AND 34 MG/DL IN 2002. THE NEXT DAY AFTER RECEIVING GLUCOSE VALUES OF 37 AND 41 MG/DL THE PT CALLED THEIR DR. THE DR TOLD THE PT TO DRINK 8 OUNCES OF ORANGE JUICE AND RE-TEST 30 MINUTES LATER. THE PT'S RE-TEST PRODUCED A GLUCOSE VALUE OF 36 MG/DL AND THE DR TOLD THE PT TO GO TO THE EMERGENCY ROOM. THE PT'S GLUCOSE LEVEL WAS ASSESSED WHILE AT THE HOSP (APPROXIMATELY TWO HOURS AFTER, THE PT DRANK 8 OUNCES OF ORANGE JUICE AND RE-TESTED THEIR BLOOD GLUCOSE), THE PT'S GLUCOSE LEVEL WAS 73 MG/DL. THE PT WAS GIVEN AN ANTIBIOTIC TO TREAT AN UNRELATED INFECTION/CONDITION AND PT WAS RELEASED FROM THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESSVIEW BLOOD GLUCOSE MONITOR SYSTEM GLUCOSE MONITOR/TEST STRIPS CGA LXN CORP. NA 20025 0601912

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R