BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1770864 · Received November 12, 2007

    Report

    Report Number
    1823260-2007-09839
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 25, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    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 AVIVA SYSTEM WITH RESULTS OF 248MG/DL AND 128MG/DL. QUALITY CONTROLS WERE 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 300700

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR BENAZEPRIL 5MG/DAY| LOVASTATIN 20MG/DAY| ASPRIN 81MG/DAY - 1 MONTH| METFORMIN 850MG 2X/DAY