BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1040938 · Received May 2, 2008

    Report

    Report Number
    1823260-2008-03727
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT HE OBTAINED THE BLOOD GLUCOSE COMPARISONS WITH RESULTS 50 MG/DL, 260 MG/DL AND 80 MG/DL ON THE ACCU-CHEK AVIVA SYSTEM. THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. NO ACTIONS TAKEN. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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 300754

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR GLUCOPHAGE 2000 MG/DAY 6 YEARS| LANTUS 40 UNITS/DAY 4 YEARS| LISINOPRIL 20 MG/DAY 4 YEARS| "POTCHLORIDE" 10 MG/DAY ONE YEAR