BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040953 · Received May 2, 2008

    Report

    Report Number
    1823260-2008-03710
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 2, 2008
    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 THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 321 MG/DL, 388 MG/DL, 188 MG/DL, 173 MG/DL, 193 MG/DL, 201 MG/DL, AND 187 MG/DL. 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 550517

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR GLIPIZIDE DOSE UNK 1-2 YRS| UNK BLOOD PRESSURE PILL| JANUVIA 50MG ONCE DAILY 1 MONTH