BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1770919 · Received November 13, 2007

    Report

    Report Number
    1823260-2007-09915
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    October 26, 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
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE AVIVA SYSTEM WITH RESULTS OF: 105 MG/DL TO 398 MG/DL; 101MG/DL TO 398MG/DL; 105MG/DL TO 254MG/DL; 102MG/DL TO 398MG/DL; 102MG/DL TO 254MG/DL; 101MG/DL TO 254MG/DL. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT 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 300756

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR TOPROL 50MG MORNING| LEVEMIR 35 UNITS/DAY| LASIX 40MG/DAY| NOVOLOG SLIDING SCALE| TOPROL 100MG EVENING