BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1780641 · Received September 27, 2007

    Report

    Report Number
    1823260-2007-08441
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    September 1, 2007
    Report Date
    September 27, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER OBTAINED RESULTS OF 341MG/DL AND 75MG/DL WITHIN 10 MINUTES ON THE ACCU-CHEK AVIVA SYSTEM. NO ACTION WAS TAKEN BASED ON THE READINGS. 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 300441

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR FLOMAX - 0.4MG/DAY - 4 YRS| NORVASC - 10MG/DAY - 10 YRS| HUMULIN - 70/30 56 UNITS/DAY - 18 YRS| B COMPLEX - 1/DAY - 8 YRS