BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1772006 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08164
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    August 25, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 AVIVA SYSTEM WITH RESULTS OF: 258MG/DL TO 76MG/DL; 360 MG/DL TO 159 MG/DL. QUALITY CONTROLS ARE EXPIRED. 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 AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 300706

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR LANTUS 40 UNITS DAILY - 5 MONTHS| GLUCOPHAGE 500MG 2X/DAY - 6-8 MONTHS