BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1761248 · Received July 23, 2007

    Report

    Report Number
    1823260-2007-06430
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    July 11, 2007
    Report Date
    July 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED 2 SETS OF DISCREPANT BLOOD GLUCOSE VALUES: 218 MG/DL, 112 MG/DL AND 121 MG/DL WITHIN 3 MINUTES; AND 324 MG/DL AND 97 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. THE CUSTOMER REPORTED NO SYMPTOMS WITH THE RESULTS. CUSTOMER REPORTED TAKING INSULIN BASED ON THE 112 MG/DL AND 97 MG/DL RESULTS. NO ADVERSE EVENTS RELATED TO THE ALLEGED MALFUNCTIONS WERE REPORTED. 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 300573

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR NOVOLOG - 9 MONTHS - INSULIN PUMP