BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1111677 · Received August 13, 2008

    Report

    Report Number
    1823260-2008-06172
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 "HI" (GREATER THAN 600MG/DL), "OVER 500MG/DL" AND 119MG/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 AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 300913

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HYDROCODONE - APPROX 3 YEARS| TOPROL - APPROX 5 YEARS| ASPIRIN - APPROX 5 YEARS| ACTOS - APPROX 3 MONTHS| METFORMIN - APPROX 15 YEARS| LIPITOR - LONG TIME| LANTUS - APPROX 3 MONTHS