BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1060624 · Received June 13, 2008

    Report

    Report Number
    1823260-2008-04731
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    June 7, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER FELT HYPOGLYCEMIC AND OBTAINED THE BLOOD GLUCOSE RESULT OF 78MG/DL ON THE ACCU-CHEK ADVANTAGE SYS. THE CUSTOMER'S NORMAL BLOOD GLUCOSE RANGE IS AROUND 70-80'S (MG/DL). SHE WAS NOT INITIALLY TREATED, BUT THE PARAMEDICS WERE CALLED. WITHIN 10 MINUTES OF THE 78MG/DL RESULT, THE CUSTOMER'S BLOOD GLUCOSE RESULT WAS 35MG/DL ON THE PROFESSIONAL METER AND THE CUSTOMER RECEIVED UNDISCLOSED INTRAVENOUS THERAPY. THE CUSTOMER FELT BETTER AFTER TREATMENT. NEW SYS SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550546

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention HUMALOG SLIDING SCALE, 1 MONTH| CORTEG 25MG/DAY, 1 MONTH| LANTUS 12 UNITS/DAY, 1 YR