BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK COMFORT CURVE

    MDR report key: 600081 · Received May 5, 2005

    Report

    Report Number
    1823260-2005-01061
    Event Type
    Injury
    Date Received
    May 5, 2005
    Report Date
    April 20, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RPEORTED DEVICE = 400 MG/DL. CUSTOMER WENT TO THE DOCTOR. DOCTOR DEVICE = 50S MG/DL. DOCTOR GAVE CUSTOMER ORANGE JUICE AND ADVISED CUSTOMER TO EAT SOMETHING WHEN LEAVING HIS OFFICE. NO CONTROLS WERE USED. A REQUEST PRODUCT AND REPLACEMENT PRODUCT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention