BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 794371 · Received December 4, 2006

    Report

    Report Number
    1823260-2006-07218
    Event Type
    Malfunction
    Date Received
    December 4, 2006
    Date of Event
    November 18, 2006
    Report Date
    November 18, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    k010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE MEASURED 222, 370, 237, & 26 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES OF EACH OTHER. NO ACTIONS WERE TAKEN OR TREATMENT WAS RECEIVED REPORTEDLY AS A RESULT. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 * 549304

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR A DAY| APRIDRA (INSULIN) - A FEW YEARS AS NEEDED 3 TIMES| LANTUS - YEARS, 100 UNITS 2 TIMES A DAY| SYMLIN - 6 MONTHS, 20 UNITS TWICE A DAY