BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1052357 · Received May 6, 2008

    Report

    Report Number
    1823260-2008-03794
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    May 3, 2008
    Report Date
    May 6, 2008
    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 REPORTEDLY RECEIVED RESULTS IN THE 200'S MG/DL AND IN THE 80'S MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 300915

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR LANTUS 25 UNITS AT NIGHT| NOVOLOG SLIDING SCALE