BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1022618 · Received March 31, 2008

    Report

    Report Number
    1823260-2008-02874
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF 480 MG/DL BACK TO BACK WITH A RESULT OF 208 MG/DL WHEN TESTS WERE PERFORMED WITHIN ONE MIN OF EACH OTHER ON THE AVIVA SYS. NO ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT WAS RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 300988

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR LANTUS| HUMALOG| BABY ASPIRIN| NEXIUM