BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 741362 · Received July 1, 2005

    Report

    Report Number
    1823260-2005-01833
    Event Type
    Malfunction
    Date Received
    July 1, 2005
    Date of Event
    June 16, 2005
    Report Date
    June 17, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    GETTING HIGH DEVICE RESULTS. CUSTOMER TOOK DEVICE TO THE DOCTOR. DEVICE = 203 MG/DL. LAB = 131 MG/DL. AT 11:15 AM AFTER RETURNING FROM THE DOCTOR, DEVICE = 175 MG/DL. AT 3 PM, DOCTOR DEVICE = 203 MG/DL. AT 3:15 PM, LAB = 131 MG/DL. CONTROLS WERE IN RANGE. NO TREATMENT. 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 548470

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other