BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1022677 · Received April 1, 2008

    Report

    Report Number
    1823260-2008-02902
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS METER RESULTS OF 298 MG/DL, 287 MG/DL, 110 MG/DL, 128 MG/DL, AND 201 MG/DL WITHIN 10 MINS ON THE AVIVA SYS. CUSTOMER REPORTED NO SYMPTOMS AND DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYS, 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 300814

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR NOVOLIN 24 UNITS MORNING| NOVOLOG 30 UNITS MORNING| NOVOLIN 14 UNITS NIGHT| NOVOLOG 32 UNITS NIGHT