BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1083639 · Received July 29, 2008

    Report

    Report Number
    1823260-2008-05852
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 225 MG/DL AND 76 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. THE FOLLOWING DAY THE CUSTOMER ALSO RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 328 MG/DL, 146 MG/DL, AND 190 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS 550502

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HUMALOG SLIDING SCALE| NPH 15 UNITS AM AND PM