BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1063591 · Received June 20, 2008

    Report

    Report Number
    1823260-2008-04881
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 98 MG/DL, 526 MG/DL, AND 379 MG/DL. NO QUALITY CONTROL INFORMATION WAS PROVIDED. 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 301159

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR NOVOLOG SLIDING SCALE - 1 YEAR| LANTUS 40 UNITS 2X/DAY - 4 YEARS