BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1141428 · Received September 3, 2008

    Report

    Report Number
    1823260-2008-05500
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY REC'D THE FOLLOWING RESULTS ON THE ACCU-CHEK AVIVA SYSTEM WITHIN 10 MINUTES: 239 MG/DL, 124 MG/DL AND 128 MG/DL. THE CUSTOMER STATES THAT HE HAS PSORIASIS AND HE DOES NOT WASH HIS HANDS BEFORE TESTING. NO REPORTED ACTION 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 301063

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR