BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUCHECK AVIVA

    MDR report key: 2093802 · Received May 11, 2011

    Report

    Report Number
    MW5020593
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ROCHE LABORATORIES
    Product Code
    LFR
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY DAUGHTER USES THE ACCUCHECK AVIVA BLOOD SUGAR METER. SHE HAS TYPE 1 (JUVENILE) DIABETES. ON THE AVIVA METER, EACH TIME A NEW CONTAINER OF TEST STRIPS IS OPENED, THE PLASTIC CODE KEY MUST ALSO BE CHANGED. DUE TO USER ERROR, MY (B)(6) DAUGHTER FAILED TO CHANGE THE CODE KEY. UNFORTUNATELY, THE SIMPLE FAILURE TO CHANGE THE KEY RESULTED IN AN A1C OF 12.9%. I AM CONCERNED THAT ANOTHER PERSON COULD MAKE THIS SAME MISTAKE, WITH POTENTIALLY CATASTROPHIC RESULTS. IN OUR CASE, HER ACTUAL BLOOD SUGAR WAS APPROX 200 POINTS ABOVE WHERE THE METER MEASURED IT. IT SEEMS REASONABLE THAT THE METER SHOULD HAVE A FAILSAFE MECHANISM. IF THE CODE KEY AND TEST STRIP DO NOT MATCH, AN ERROR MESSAGE SHOULD POP UP ON THE SCREEN. ACCUCHECK AVIVA TEST STRIPS BY ROCHE LABORATORIES WERE ALSO USED. (B)(4). LOT 303007. CATALOG NUMBER 04528662001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUCHECK AVIVA AVIVA BLOOD GLUCOSE METER LFR ROCHE LABORATORIES NONE SPECIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening CAT 04528662001| ACCUCHECK AVIVA TEST STRIPS BY ROCHE, LOT 303004