BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 512331 · Received February 18, 2004

    Report

    Report Number
    1823260-2004-00083
    Event Type
    Injury
    Date Received
    February 18, 2004
    Date of Event
    February 11, 2004
    Report Date
    February 12, 2004
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER USED DEVICE TO CHECK THEIR GLUCOSE AT 6:00 AND OBTAINED A RESULT OF 116MG/DL. DOSED 13 UNITS OF INSULIN. BECAME UNRESPONSIVE WHILE EATING. PARAMEDICS WERE CALLED AND RECEIVED A READING OF 34 MG/DL ON THEIR INSTRUMENT. PATIENT WAS GIVEN A GLUCOSE INJECTION AND PUT ON AN IV. THEY WERE TRANSPORTED AND OBSERVED AT THE HOSP. THEY ATE A SANDWHICH AND WERE ABLE TO GO HOME. REPLACING DEVICE. REQUESTED RETURN OF SUSPECT DEVICE 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 546736

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DAY Hospitalization| R