BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 511113 · Received February 9, 2004

    Report

    Report Number
    1823260-2004-00059
    Event Type
    Injury
    Date Received
    February 9, 2004
    Date of Event
    February 3, 2004
    Report Date
    February 3, 2004
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER'S FAMILY MEMBER FOUND CUSTOMER UNCONSCIOUS. FAMILY MEMBER USED THE DEVICE TO CHECK CUSTOMER'S GLUCOSE AFTER TRYING TO GIVE CUSTOMER ORANGE JUICE. FAMILY MEMBER OBTAINED A RESULT OF 129 MG/DL. FAMILY MEMBER CALLED THE EMTS AND WHEN THEY ARRIVED THEY CHECKED CUSTOMER'S GLUCOSE AND THE LEVEL WAS 16 MG/DL. CUSTOMER WAS TREATED WITH A DEXTROSE IV AND TAKEN TO THE ER. CUSTOMER WAS GIVEN BREAKFAST AND RELEASED. CUSTOMER HAS BEEN HAVING DIFFICULTY WITH HYPOGLYCEMIA IN THE MORNING AND CUSTOMER'S DOCTOR REMOVED CUSTOMER FROM GLYPIZIDE. CONTROLS WERE NOT USED ON THE SYSTEM. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    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 546873

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R