BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1004043 · Received February 27, 2008

    Report

    Report Number
    1823260-2008-01927
    Event Type
    Injury
    Date Received
    February 27, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY TESTED 185 MG/DL ON THE ADVANTAGE SYSTEM WHILE EXHIBITING HYPOGLYCEMIC SYMPTOMS. CUSTOMER WAS UNRESPONSIVE SO THE PARAMEDICS WERE CALLED. THE PARAMEDICS OBTAINED A RESULT OF 30 MG/DL ON THEIR DEVICE AND ADMINISTERED AN IV OF UNKNOWN SUBSTANCE. THE CUSTOMER WAS ALSO GIVEN GLUCAGON. A COMPARISON REPORTED FROM THE NEXT DAY SHOWS THE PATIENT OBTAINED RESULTS OF APPROXIMATELY 300 MG/DL, APPROXIMATELY 310 MG/DL AND 95 MG/DL ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN AT THIS TIME. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT. CUSTOMER OBTAINED RESULTS ON 2 STRIP VIALS OF THE SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE-LFR NBW ROCHE DIAGNOSTICS 549947

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention NOVOLIN 70/30 - 50 UNITS/DAY