BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1020214 · Received March 26, 2008

    Report

    Report Number
    1823260-2008-02781
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 54MG/DL AND 110MG/DL. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. CUSTOMER DOES NOT HAVE STRIPS FROM THE EVENT; 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR BYETTA 5MCG PEN AT NIGHT| BYETTA 5MCG PEN 1/2 HOUR - AFTER GLIPIZIDE| GLIPIZIDE 2.5MG DAILY