BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE XL

    MDR report key: 477206 · Received August 1, 2003

    Report

    Report Number
    MW1029213
    Event Type
    Malfunction
    Date Received
    August 1, 2003
    Date of Event
    July 9, 2003
    Report Date
    July 30, 2003
    Manufacturer
    BAYER CORP
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    DURING THE COURSE OF TREATING A PRIORITY 3 SUSPECTED CVA A 2ND SET OF VITAL SIGNS WAS GLUCOMTER READ "LO". PER PROTOCOL AND WITH THE GLUCOMETER AS A DIAGNOSTIC TOOL; ALS WAS INITIED INCLUDING DEXTROSE 50% IVP. UPON ARRIVAL AT HOSPITAL, LAB RESULTS FOR THIS PT FOUND THEIR GLUCOSE LEVEL TO BE 394. - GLUCOMETER GAVE A FALSE READING OF BLOOD SAMPLE. PTS. BLOOD GLUCOSE WAS DETERMINED TO BE MUCH HIGHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE XL HANDHELD GLUCOMETER CFR BAYER CORP 3901B *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other