BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1052284 · Received May 23, 2008

    Report

    Report Number
    1823260-2008-04278
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 500MG/DL, 300MG/DL, AND 200MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. CUSTOMER TOOK 14 UNITS NOVOLOG INSULIN BASED 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 300987

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR ALTACE| LEVEMIR - 20 UNITS/DAY| NOVOLOG - SLIDING SCALE