BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1061541 · Received June 17, 2008

    Report

    Report Number
    1823260-2008-04786
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED METER RESULTS OF 44 MG/DL, 65 MG/DL, 78 MG/DL, 71 MG/DL, 78 MG/DL, AND 73 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED NO PT SYMPTOMS AND 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 550613

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR APIDRA 24 UNITS/DAY - 2 WEEKS| LANTUS 23 UNITS/DAY - 6 MONTHS