BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESSVIEW BLOOD GLUCOSE MONITOR SYSTEM

    MDR report key: 404849 · Received July 9, 2002

    Report

    Report Number
    2031335-2002-00004
    Event Type
    Injury
    Date Received
    July 9, 2002
    Date of Event
    June 18, 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
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A DIABETIC PATIENT RECEIVED GLUCOSE VALUES OF 41 AND 77 MG/DL IN 2002. THE PATIENT BECAME DISORIENTED (DID NOT KNOW WHAT DAY IT WAS) AND LAID DOWN IN BED WHILE FAMILY MEMBER CALLED THE PARAMEDICS. APPROXIMATELY 20-30 MINUTES LATER THE PARAMEDICS ARRIVED. THE PATIENT'S GLUCOSE LEVEL WAS ASSESSED BY THE PARAMEDICS SHORTLY AFTER THEIR ARRIVAL. PATIENT'S GLUCOSE LEVEL WAS 24 OR 25 MG/DL. THE PARAMEDICS FED THE PATIENT A GLUCOSE GEL, THE PATIENT REGAINED RETENTIVENESS AND THE PARAMEDICS CONCLUDED THE PATIENT WAS FINE.

    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 0700201

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention