BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK AVIVA TEST STIPS

    MDR report key: 1061502 · Received June 17, 2008

    Report

    Report Number
    1823260-2008-04777
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 17, 2008
    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 REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 267MG/DL, 134 MG/DL, 150 MG/DL, 134 MG/DL, AND 151 MG/DL. 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-CHECK AVIVA TEST STIPS BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS 301110

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR