BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1002102 · Received February 20, 2008

    Report

    Report Number
    1823260-2008-01723
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINS: 278 MG/DL, 236 MG/DL, 179 MG/DL, AND 135 MG/DL. 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 300871

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR GLIPIZIDE 10 MG 1/DAY 7-8 YRS| METFORMIN 500 MG 3/DAY 7-8 YRS| ACTOS 30 MG 1/DAY 7-8 YRS