BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1243214 · Received November 7, 2008

    Report

    Report Number
    1823260-2008-08250
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED OBTAINED BLOOD GLUCOSE RESULTS OF 452 MG/DL, "360 SOMETHING" MG/DL, AND 184 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE ADVANTAGE SYSTEM. NO SYMPTOMS, ACTION OR TREATMENT BASED ON THE RESULTS WAS REPORTED. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. 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 550781

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR ACTOS - FEW MONTHS| GLYBURIDE - 4-5 YEARS