BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1770539 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09206
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 5, 2007
    Report Date
    October 22, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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: 457 MG/DL AND 164 MG/DL, 457 MG/DL AND 173 MG/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 300648

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR LISINOPRIL - 20MG/DAY| AMARYL - 4MG/DAY| HYDROCHLOROTHIAZIDE - 25MG/DAY| ASPIRIN - 280MG/DAY| METFORMIN - 1000MG 2X/DAY