BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1061509 · Received June 17, 2008

    Report

    Report Number
    1823260-2008-04784
    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

    THE CUSTOMER OBTAINED A 509 MG/DL AND 123 MG/DL BLOOD GLUCOSE COMPARISON ON THE ACCU-CHEK AVIVA SYSTEM. THE REPORTER STATES HE OBTAINED AN ADDITIONAL COMPARISON WITH BLOOD GLUCOSE RESULTS 380 MG/DL AND 143 MG/DL ON THE ACCU-CHEK AVIVA SYSTEM. ON BOTH OCCASIONS, TEST RESULTS WERE OBTAINED WITHIN 10 MINUTES. NO REPORTED ACTION TAKEN. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURNED REQUESTED.

    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 300997

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR METFORMIN| GLYBRIDE