BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1770732 · Received September 5, 2007

    Report

    Report Number
    1823260-2007-07786
    Event Type
    Malfunction
    Date Received
    September 5, 2007
    Date of Event
    August 18, 2007
    Report Date
    September 5, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 328 MG/DL AND 142 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULT. 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 300650

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR JANUVIA 100MG ONCE DAILY - 8 MONTHS| METFORMIN 1000MG 2/DAY - 10 YEARS| AMARYL 1MG ONCE DAILY - 2 MONTHS