BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1012757 · Received March 12, 2008

    Report

    Report Number
    1823260-2008-02356
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S HUSBAND REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE AVIVA SYS WITH RESULTS OF 242MG/DL AND 127MG/DL. NO QUAL CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PROD 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 300912

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR BABY ASPIRIN 81 MG/DAY - 2 YRS| HUMALOG 22 UNITS AM - 2.5 YRS| HUMALOG 6 UNITS PM - 2.5 YRS| ATACAND 16 MG/DAY - 2 YRS| AMLODIPINE 10 MG/DAY - 1 YR