BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 737882 · Received July 13, 2006

    Report

    Report Number
    1823260-2006-03532
    Event Type
    Malfunction
    Date Received
    July 13, 2006
    Date of Event
    June 25, 2006
    Report Date
    June 26, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE MEASURED 375 MG/DL AND SEVERAL HOURS LATE RMEASURED 150, 382, 320, & 140 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINS OF EACH OTHER. NO ACTIONS WERE TAKEN OR TREATMENT WAS REC'D REPORTEDLY AS A RESULT. A REQUEST WAS MADE FOR THE RETURN OF THE SUPPORT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIAGNOSTICS * 549113

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR ACCU-CHEK ADVANTAGE METER| CV181 SAXOGLIPTIN A AND B| METFORMIN