BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1060064 · Received June 12, 2008

    Report

    Report Number
    1823260-2008-04681
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 25, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 410 MG/DL, 190 MG/DL, 198 MG/DL, AND 189 MG/DL ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND 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 CORP. 550089

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR ATENOLOL 15 YEARS 50 MG/DAY| GLYBURIDE 2 YEARS 2.5 MG/DAY| FORMOTEROL FUMURATE 4 YEARS| POTASSIUM CHLORIDE 60/DAY| MOMETASONE FUROATE 4 YEARS 440 MCG/DAY| COUMADIN 15 YEARS| ALBUTEROL 4-5 YEARS| "ANAPORIL" 10 YEARS