BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 734656 · Received June 27, 2006

    Report

    Report Number
    1823260-2006-03100
    Event Type
    Malfunction
    Date Received
    June 27, 2006
    Date of Event
    June 7, 2006
    Report Date
    June 7, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE RESULTS OF 222, 463, & 198 MG/DL WHEN PERFORMED ONE MIN APART. NO ACTIONS OR TREATMENT REC'D 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 NBW ROCHE DIAGNOSTICS NA 548971

    Patients

    Seq Age Sex Outcome Treatment
    1 * ACCU-CHEK ADVANTAGE III METER