BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771191 · Received February 18, 2008

    Report

    Report Number
    1823260-2008-01627
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 182 MG/DL AND 80 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 549512

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR AMARYL - 7 YEARS 8MG/DAY| METFORMIN - 7 YEARS 1000MG/DAY| LANTUS - 3-4 MONTHS 24 UNITS/DAY| METOPROLOL - 7 YEARS 25MG/DAY| HYDROCHLOROTHIAZIDE - 7 YEARS 25MG/DAY