BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1781016 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06540
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    June 29, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 206 MG/DL, 24 MG/DL, AND 98 MG/DL. THE RESULT OF 24 MG/DL WAS COMPARED WITH A RESULT OF 133 MG/DL OBTAINED ON A PROFESSIONAL'S DEVICE. 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-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 300458

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR PREVACID 30MG ONCE DAILY - 30 YEARS| DARVOCET 200/1300MG AS NEEDED - 4-5 YEARS| TOPROL XL 50MG ONCE DAILY| LOPEROMIDE 2MG AS NEEDED - 5 YEARS| SINGULAIR 10MG ONCE DAILY - 5 YEARS| ADVAIR 500MG TWICE DAILY - 4 YEARS| ALBUTEROL NEBULIZER 2/DAY - 3-4 YEARS| AVANDAMET 4/1000MG 2/DAY - 2 YEARS| GLUCOPHAGE 500MG ONCE DAILY - 12 YEARS| ASPIRIN 325MG ONCE DAILY - 3 WEEKS| LISINOPRIL 10MG ONCE DAILY - 18 YEARS| DEMADEX 40MG ONCE DAILY - 6 MONTHS| METOCLOPRAMIDE 10MG 3/DAY - 32 YEARS| COMBIVENT INHALER AS NEEDED - 10 YEARS| LORATIDINE 10MG ONCE DAILY - 2 MONTHS