BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771190 · Received February 5, 2008

    Report

    Report Number
    1823260-2008-01258
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING TO A PROFESSIONAL METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF 265 MG/DL ON CUSTOMER'S METER AND 115 MG/DL ON A PROFESSIONAL METER. NO QUALITY CONTROLS WERE RUN DURING THE CALL. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 549909

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR METFORMIN - 500MG 2X/DAY| ARTHRITIS PILLS| CHOLESTEROL PILLS| BLOOD PRESSURE PILLS