BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761127 · Received July 19, 2007

    Report

    Report Number
    1823260-2007-06305
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    June 27, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT ACCU-CHEK ADVANTAGE SYSTEM INITIALLY HAD RESULT OF 241 MG/DL. WITHIN TEN MINUTES THE CUSTOMER WAS RETESTED ON A PROFESSIONAL METER AT THE CLINIC WITH RESULT OF 74 MG/DL. CUSTOMER WAS SHAKY AND ATE A PIECE OF CANDY PROVIDED BY THE HEALTH PROFESSIONAL. NO SUBSEQUENT TEST WAS DONE AFTER EVENT. NO ADVERSE EVENT REPORTED. SENT NEW SYSTEM 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 549722

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR INSULIN R - 10 UNITS, PM, 1 WEEK| INSULIN R - 30UNITS, AM, 1 WEEK| INSULIN N - 15UNITS, AM, 1 WEEK| INSULIN N - 10 UNITS, PM, 1 WEEK