BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1770931 · Received November 13, 2007

    Report

    Report Number
    1823260-2007-09906
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    October 23, 2007
    Report Date
    November 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF 201 MG/DL BACK TO BACK WITH A RESULT OF 106 MG/DL WHEN TESTING WAS PERFORMED 1 MINUTE A PART ON THE AVIVA SYSTEM. NO ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT RECEIVED. 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 300757

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR LANTUS, 3 MOS - 15 UNITS ONCE DAILY