BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770688 · Received October 29, 2007

    Report

    Report Number
    1823260-2007-09400
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    August 4, 2007
    Report Date
    October 29, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED RESULTS 420MG/DL AND 190MG/DL WITHIN 10 MINUTES ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE CUSTOMER TOOK INSULIN BASED ON READINGS. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR LANTUS 35 UNITS/DAY - 1 YEAR| NOVOFLEX PEN 2 UNITS IF BG 1 - 1 YEAR