BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESSVIEW BLOOD GLUCOSE MONITOR

    MDR report key: 392505 · Received May 2, 2002

    Report

    Report Number
    2031335-2002-00002
    Event Type
    Injury
    Date Received
    May 2, 2002
    Date of Event
    March 29, 2002
    Report Date
    April 30, 2002
    Manufacturer
    LXN CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE DIABETIC PT OBTAINED A GLUCOSE VALUE OF 134 MG/DL, ATE BREAKFAST AND THEN SAT TO WATCH TV IN WHEELCHAIR. THE PT'S FAMILY MEMBER ARRIVED TO DELIVER PT'S LUNCH AND THE PT WAS "PASSED OUT" IN PT'S WHEELCHAIR. THE PT'S FAMILY MEMBER TOOK THE PT TO THE HOSPITAL. PT WAS STABILIZED AND LATER RELEASED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R