BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1200125 · Received October 15, 2008

    Report

    Report Number
    1823260-2008-07622
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 27, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE AVIVA SYSTEM WITH RESULTS OF 202 MG/DL AND 94 MG/DL. MOTHER REPORTS CUSTOMER HAS BEEN STORING STRIPS OUTSIDE OF CONTAINER WHEN SHE GOES TO SCHOOL; UNABLE TO CONFIRM THAT STRIPS USED WERE STORED OUTSIDE OF CONTAINER. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A 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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR GLUCOPHAGE - 3 YEARS| THYROID MED - 3 YEARS| LANTUS - 3 YEARS| NOVOLOG - 3 YEARS