BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1070485 · Received July 7, 2008

    Report

    Report Number
    1823260-2008-05236
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    January 28, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULT COMPARISONS OF 936 MG/DL COMPARED TO "100S" MG/DL WITHIN 10 MINUTES AND 400 MG/DL COMPARED TO "150S" MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO TREATMENT OR ADVERSE EVENTS WERE REPORTED. CUSTOMER NO LONGER HAS PRODUCT FOR RETURN; REPLACEMENT WAS SENT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR OMEPRAZOLE - 3 YEARS| "SIMVASTIN" - 8 MONTHS| CITALOPRAM HYDROBROMIDE - 3 YEARS| "METROPOLOL TARTRATE" - 1 YEAR