BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1123924 · Received August 15, 2008

    Report

    Report Number
    1823260-2008-06248
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    February 13, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULT OF 99 MG/DL ON THE AVIVA SYSTEM. CUSTOMER SELF TREATED, AND RE-TESTED WITHIN 10 MINUTES WITH RESULTS OF 250 MG/DL AND 160-170 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECTED 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 300915

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR "70-30" 60UNITS TWICE/DAY