BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1780565 · Received September 19, 2007

    Report

    Report Number
    1823260-2007-08214
    Event Type
    Malfunction
    Date Received
    September 19, 2007
    Date of Event
    September 5, 2007
    Report Date
    September 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS OF 338 MG/DL AND 159 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE AVIVA SYSTEM. THE CUSTOMER REPORTED HAVING NO SYMPTOMS AND REPORTED NO TREATMENT OR ACTION. 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 300567

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LANTUS - 2 YRS - 30 UNITS AM| METFORMIN - 1000MG TWICE DAILY| AMARYL (GENERIC) - 4MG TWICE DAILY