BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK CONFORT CURVE TEST STRIPS

    MDR report key: 1141403 · Received September 3, 2008

    Report

    Report Number
    1823260-2008-05492
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: HI (RESULT GREATER THAN 600MG/DL) AND 126MG/DL; HI (RESULT GREATER THAN 600MG/DL) AND 128MG/DL. 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 CONFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550612

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR NORVASC - 5 YEARS 10MG/DAY| GLIPIZIDE - 2-3 YEARS 5MG/DAY| TOPROL XL - 5 YEARS 50MG/DAY