BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1781018 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06537
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    July 13, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES CUSTOMER REPORTEDLY RECEIVED RESULTS OF 409 MG/DL AND 181 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 549730

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR NOVOLOG - 4 UNITS 3/PER DAY| NPH INSULIN - 8 UNITS PM| NPH INSULIN - 8 UNITS AM