BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 2760106 · Received November 1, 2004

    Report

    Report Number
    1823260-2004-01216
    Event Type
    Malfunction
    Date Received
    November 1, 2004
    Date of Event
    October 17, 2004
    Report Date
    October 17, 2004
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER DOESN'T FEEL THE DEVICE IS READING CORRECTLY. THE DEVICE WAS USED TO TEST A PT AND THE RESULT WAS 376MG/DL AND A LAB RESULT WAS 244MG/DL. THE DEVICE WAS USED TO TEST A SECOND PT AND THE RESULT WAS 509MG/DL AND THE LAB RESULT WAS 292MG/DL. A THIRD PT WAS TESTED AND THE RESULT WAS 550MG/DL AND THE LAB RESULT WAS 375MG/DL. NO TREATMENT WAS GIVEN TO THE PTS BASED ON THE DEVICE. THE POCC CALLED AND HE FEELS IT HAS TO DO WITH NURSE EDUCATION, NOT THE DEVICE. CONTROLS WERE IN USE, BUT NO VALUES WERE PROVIDED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE. THE CUSTOMER DECLINED REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA 548119

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention