BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1053182 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04325
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 314 MG/DL AND A RESULT OF 114 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 301070

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR