BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1190633 · Received October 6, 2008

    Report

    Report Number
    1823260-2008-07371
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF 248 MG/DL ON THE ADVANTAGE SYSTEM, 70 MG/DL ON A PHYSICIAN'S SYSTEM, AND A 70 MG/DL LAB RESULT WITHIN 10 MINUTES. CUSTOMER REPORTED FATIGUE, DID NOT TREAT OR ACT ON RESULTS. 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 550674

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR GLIPIZIDE 20 MG/DAY 5 YEARS| ACTOS 15 MG/DAY 7 MONTHS