BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1061145 · Received June 13, 2008

    Report

    Report Number
    1823260-2008-04723
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S BOYFRIEND REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE AVIVA SYSTEM WITH RESULTS OF 595 MG/DL AND 229 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 CORP. 301070

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR METFORMIN: 1000MG AM| LANTUS: 14 UNITS PM| HUMALOG: 8 YEARS| ACTOS: 30MG AM-1 YEAR