BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1070101 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05160
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 295MG/DL AND 82MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. AN ADDITIONAL COMPARISON REPORTED RESULTS OF 408MG/DL, 186MG/DL, AND 116MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM 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 300790

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR INSULIN 28 YEARS 32 UNITS/DAY| HUMALOG 10 YEARS AS NEEDED