BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1041190 · Received May 9, 2008

    Report

    Report Number
    1823260-2008-03879
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED METER RESULTS OF HI, WHICH ON THE ADVANTAGE SYS INDICATES RESULT IN EXCESS OF 600 MG/DL, AND 64 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYS. CUSTOMER REPORTED A RESULT OF 63 MG/DL 11 MINUTES LATER, FELT SYMPTOMS OF HYPOGLYCEMIA, SELF TREATED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYS, 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 550500

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HYDROCORTISONE 25 MG/DAY| COZAAR 50 MG/2/WEEK| LIPITOR 20 MG/DAY| NOVOLOG 15 UNITS/3/DAY| DIPHENOXYLATE/ATROPINE 2.5 MG/DAY| LANTUS 46 UNITS/DAY