BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 603695 · Received May 16, 2005

    Report

    Report Number
    1823260-2005-01231
    Event Type
    Injury
    Date Received
    May 16, 2005
    Date of Event
    May 6, 2005
    Report Date
    May 10, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED FEELING LOW AND DRINKING A MOUNTAIN DEW. AT 12:04 PM, DEVICE = 212 MG/DL. CUSTOMER FELT ILL. EMERGENCY MEDICAL TECHNICIAN (EMT) ARRIVED WITHIN 30 MINUTES. EMT DEVICE = 63 MG/DL. AT 12:19 PM, CUSTOMER'S DEVICE = 224 MG/DL. EMT GAVE CUSTOMER GLUCOSE TABLETS. NO CONTROLS WERE USED. A REQUEST WAS MADE FOR RETURN PRODUCT AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA 548349

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention