BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1060105 · Received June 10, 2008

    Report

    Report Number
    1823260-2008-04599
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 10, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 100MG/DL, 111MG/DL, 152MG/DL, 153MG/DL, 117MG/DL, AND 227 MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. AN ADDITIONAL COMPARISON REPORTED RESULTS OF 300MG/DL, 117MG/DL, 139MG/DL, AND 115MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM 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 301094

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR GLYBURIDE - 16 YEARS| NOVOLIN-R - 1 YEAR| METFORMIN - 16 YEARS| NOVOLIN -N - 1 YEAR