BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1052265 · Received May 6, 2008

    Report

    Report Number
    1823260-2008-03764
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 2 STRIP LOTS ARE UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 297 MG/DL, 256MG/DL, AND 256MG/DL ON THE AVIVA SYSTEM WHILE A PROFESSIONAL DEVICE RETURNED RESULTS OF 98MG/DL, 95MG/DL, AND 95MG/DL. ALL RESULTS WERE OBTAINED WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. CUSTOMER USED 3 DIFFERENT STRIP VIALS TO OBTAIN THE RESULTS. ONLY ONE STRIP LOT WAS REPORTED AND CUSTOMER DID NOT PROVIDE WHICH STRIP LOT PRODUCED SPECIFIC RESULTS. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER 2 VIALS ARE UNAVAILABLE FOR RETURN.

    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 300776

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR ANDROGEL - 3-4 MONTHS 5 G/DAY| GLUCOPHAGE - 2000MG/DAY| NOVOLOG - SLIDING SCALE