BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1051711 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04123
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT SHE OBTAINED THE BLOOD GLUCOSE RESULTS OF 200 MG/DL AND 90 MG/DL ON THE ACCU-CHEK AVIVA SYSTEM. THE RESULTS WERE OBTAINED WITHIN A 10 MIN TIMEFRAME. NO REPORTED ACTIONS TAKEN. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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 CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR BYETTA 5"MG"/2X| HUMALOG 75/25| NOVOLOG SLIDING SCALE