BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 724357 · Received January 31, 2006

    Report

    Report Number
    1823260-2006-00431
    Event Type
    Malfunction
    Date Received
    January 31, 2006
    Date of Event
    January 6, 2006
    Report Date
    January 9, 2006
    Manufacturer
    *
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE BLOOD GLUCOSE MONITORING DEVICE SYSTEM WAS READING HIGH WITH A RESULT OF 294 MG/DL AND WENT TO THE DOCTOR TO HAVE GLUCOSE TESTED. IT WAS REPORTED THE DOCTOR DEVICE READ 88 MG/DL AND NO TREATMENT WAS RECEIVED. 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 BLOOD GLUCOSE NBW * NA 548208

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 1.ACCU-CHEK ADVANTAGE, 2.ZYPREXA,| 6.NEXIUM, 7.VYTORIN.| 3.STRATTERA, 4.TOPAMAX, 5.INDERAL,