BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1033179 · Received April 23, 2008

    Report

    Report Number
    1823260-2008-03486
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S SON REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF 270MG/DL AND 75MG/DL. NO QUAL CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PROD 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 550086

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR CELEXA - 10MG IN AM| METFORMIN - 100MG 2X/DAY| CALCIUM - 600MG 2X/DAY| GLYBURIDE 4MG IN AM| LOVASTATIN - 40MG IN PM| CICLOPIROX - DAILY| ASPIRIN - 81MG DAILY| MULTIVITAMIN - 1 TAB DAILY| NOVOLOG SLIDING SCALE| DIOVAN - 40MG IN AM