BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1023847 · Received April 2, 2008

    Report

    Report Number
    1823260-2008-02933
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE ACTIVE SYSTEM WITH RESULTS OF LO (<10 MG/DL) AND 147 MG/DL. NO QUALITY CONTROLS WERE RUN DURING THE CALL. 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 22969933

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR VASOTEC 2.5 MG/DAY 2 YRS| GLUCOTROL XL 5 MG/DAY 2 YRS