BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1172574 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07023
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACCU-CHEK ADVANTAGE SYSTEM WITHIN 10 MINUTES: 130MG/DL, 63MG/DL, AND 62MG/DL. THE CUSTOMER FELT HYPOGLYCEMIC. SHE ATE A TOAST WITH JELLY AND FELT BETTER 10 MINUTES AFTER TREATMENT. 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 550502

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR LANTUS - 6-7 YEARS| HUMALOG - 18 YEARS