BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040968 · Received May 8, 2008

    Report

    Report Number
    1823260-2008-03834
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    May 4, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF HI (GREATER THEN 600 MG/DL) AND 77 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. LOW BLOOD GLUCOSE SYMPTOMS REPORTED WITH THESE RESULTS; CUSTOMER WAS ABLE TO SELF TREAT. LATER THAT DAY CUSTOMER REPORTEDLY RECEIVED RESULTS OF 369 MG/DL AND 82 MG/DL WITHIN 10 MINUTES THE ADVANTAGE SYSTEM. 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 550537

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR LANTUS SLIDING SCALE - 10 YEARS| HUMALOG 10-17 UNITS 3/DAILY - 10 YEARS