BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1780574 · Received September 26, 2007

    Report

    Report Number
    1823260-2007-08419
    Event Type
    Malfunction
    Date Received
    September 26, 2007
    Date of Event
    August 23, 2007
    Report Date
    September 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 525 MG/DL AND 123 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE 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 549801

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR ATARAX 25MG AT BEDTIME - 2 YEARS| METFORMIN 1000MG TWICE DAILY - 5 YEARS| NORVASC 5 MG ONCE DAILY 20 YEARS| CLONAZEPAM 1MG AT BEDTIME - 1 YEAR| ALBUTEROL INHALER AS NEEDED - 20 YEARS| CYMBALTA 60 MG ONCE DAILY 1 MONTH| ASPIRIN 325 MG ONCE DAILY 3 YEARS| ACCOLADE 20MG TWICE DAILY - 8 YEARS| CLONIDINE 2/10TH MG 2/DAILY - 4 YEARS