BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1232767 · Received November 14, 2008

    Report

    Report Number
    1823260-2008-08422
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    November 8, 2008
    Report Date
    November 14, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF 329 MG/DL AND 155 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, TOOK NORMAL MEDICATION. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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 550801

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR LUMIGAN .03/% 1 DROP/EYE| CYMBALTA 60 MG/DAY| GUANFACINE 4 MG/DAY| PLAVIX 75 MG/DAY| NIFEDIPINE XL 90 MG/DAY| HYDROCHLOROTHIAZIDE 25 MG/DAY| CARBATROL| METFORMIN XR 1000 MG/DAY| LAMICTAL 400 MG/DAY| CARVEDILOL 12.5 MG/DAY| AVAPRO 300 MG/DAY| TIMOLOL 0.5/% 1 DROP/EYE| REGLAN 30 MG/DAY| NOVOLIN 70/30 SLIDING SCALE