BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1061508 · Received June 17, 2008

    Report

    Report Number
    1823260-2008-04783
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 ACTIVE SYSTEM WITH RESULTS OF 240MG/DL AND 122MG/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 ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS 22974231

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR FUROSEMIDE 80MG/DAY| ZOLOFT 50MG/DAY| PROTONIX 40MG/DAY - 2 YEARS| RANITIDINE 150MG 2X/DAY| ULTRAM 50MG EVERY 6 HR| PHENERGAN 25MG EVERY 6HR| GEMFIBROZIL 60MG/DAY| METFORMIN 850MG 3X /DAY| GLYBURIDE 5MG 2X/DAY