BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1181537 · Received September 25, 2008

    Report

    Report Number
    1823260-2008-07151
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 MINUTES: 496 MG/DL, 316 MG/DL, AND 149 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 300985

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR LISINOPRIL - 5 MG| REQUIP - 4MG 2 TABS/DAY| CYMBALTA - 60 MG| METFORMIN - 1000MG 2 TABS/DAY