BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1052347 · Received May 6, 2008

    Report

    Report Number
    1823260-2008-03797
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTS BACK TO BACK TESTING TO A PROFESSIONAL METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF 450 MG/DL ON CUSTOMER'S METER AND 150 MG/DL ON PROFESSIONAL METER. NO QUALITY CONTROLS WERE RUN DURING THE CALL. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR 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 TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550509

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR METFORMIN 1000MG 2X/DAY - 1 MONTH| BENAZEPRIL 12.5MG/DAY - 2 YEARS| GLIPIZIDE 10MG IN AM - 2 WKS