BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK COMFORT CURVE

    MDR report key: 577547 · Received February 28, 2005

    Report

    Report Number
    1823260-2005-00304
    Event Type
    Injury
    Date Received
    February 28, 2005
    Date of Event
    January 28, 2005
    Report Date
    January 29, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SUSPECT DEVICE RESULTS WERE 200, 181, 207 AND 170 MG/DL. THE USER DOSED MORE INSULIN AND BECAME INCOHERENT. SPOUSE CALLED AN AMBULANCE AND THE EMERGENCY MEDICAL TECHNICIANS GIVEN AN IV AND TAKEN TO THE HOSP. CONTROLS WERE NOT USED. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE LFR ROCHE DIAGNOSTICS NA 546737

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R