BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1780371 · Received September 14, 2007

    Report

    Report Number
    1823260-2007-08096
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    August 29, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS OF 585 MG/DL, 246 MG/DL, 212 MG/DL, AND 306 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE ADVANTAGE SYSTEM. THE CUSTOMER REPORTED HAVING NO SYMPTOMS AND DID NOT TREAT OR ACT BASED ON RESULTS. 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 549535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA GLIPIZIDE - 10MG DAILY| ACTOS - 45MG DAILY| BYETTA - 5MG TWICE DAILY| GEMFIBROZIL - 600MG TWICE DAILY| METFORMIN - 1000MG TWICE DAILY