BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 576216 · Received February 23, 2005

    Report

    Report Number
    1823260-2005-00284
    Event Type
    Injury
    Date Received
    February 23, 2005
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SUSPECT DEVICE RESULT WAS 400 MG/DL. THE USER DOSED INSULIN AND PASSED OUT. THEY BECAME COHERENT AND DRANK JUICE AND MOUNTAIN DEW. THEY DID NOT SEEK MEDICAL TREATMENT. CONTROLS WERE NOT USED. 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 548210

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention