BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1770549 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09207
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 9, 2007
    Report Date
    October 22, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS OF 300 MG/DL AND 120 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE AVIVA SYSTEM. CUSTOMER DID NOT REPORT SYMPTOMS. CUSTOMER DID NOT TREAT OR ACT ON RESULTS. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 300739

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR GLUCOTROL - LONG TIME - 10MG AM| AVANDIA - 8 MG AM AND PM| BYETTA - 6 MONTHS - 10MCG TWICE DAILY