BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESSVIEW BLOOD GLUCOSE MONITOR SYSTEM

    MDR report key: 392531 · Received May 2, 2002

    Report

    Report Number
    2031335-2002-00001
    Event Type
    Injury
    Date Received
    May 2, 2002
    Date of Event
    March 31, 2002
    Report Date
    May 1, 2002
    Manufacturer
    LXN CORPORATION
    Product Code
    CGA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A DIABETIC PATIENT RECEIVED LOW GLUCOSE LEVELS ON THE DAY OF THE EVENT WHEN TESTING ON EV MONITOR. FAMILY MEMBERS CALLED 911. EMT CONFIRMED LOW GLUCOSE LEVEL, GAVE SUGAR WATER AND TOOK VITAL CHECKS. THE DIABETIC INDIVIDUAL WAS TRANSPORTED TO HOSPITAL, STABILIZED AND LATER RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESSVIEW BLOOD GLUCOSE MONITOR SYSTEM GLUCOMONITOR/TEST STRIPS CGA LXN CORPORATION NA 80270601522

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R