BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1051722 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04116
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF 300 MG/DL, 274 MG/DL, 119 MG/DL AND 119 MG/DL. NO QUALITY CONTROLS WERE RUN. 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 CORP. 550613

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR BENICAR 20-12.5 MG/DAY - 1 MONTH| METFORMIN 500MG 2X/DAY| SYMLIN PEN 120 UNITS 3X/DAY| NOVOLOG 70/30 - 1 YEARS