BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1770543 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09217
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 8, 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
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS OF 208 MG/DL AND 97 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE AVIVA SYSTEM. CUSTOMER REPORTED HAVING NO SYMPTOMS. CUSTOMER DID NOT TREAT OR ACT ON THE 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 300629

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR