BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 517058 · Received March 19, 2004

    Report

    Report Number
    1823260-2004-00143
    Event Type
    Injury
    Date Received
    March 19, 2004
    Date of Event
    March 5, 2004
    Report Date
    March 8, 2004
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER TOOK BLOOD GLUCOSE READING AND RECEIVED A RESULT OF 144 MG/DL. ONE HOUR LATER READING WAS 119 MG/DL. CUSTOMER TOOK REGULAR MEDICATIONS AND STARTED TO FEEL BAD. WENT TO THE HOSPITAL AND THEY TESTED BLOOD GLUCOSE AND RECEIVED A RESULT OF 30 MG/DL. CUSTOMER WAS GIVEN GLUCOSE. NO CONTROLS WERE BEING USED. A REQUEST WAS MADE FOR THE RETURN OF SUSPECT DEVICE 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 CFR ROCHE DIAGNOSTICS CORP. NA 546829

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention