BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1780557 · Received September 19, 2007

    Report

    Report Number
    1823260-2007-08199
    Event Type
    Malfunction
    Date Received
    September 19, 2007
    Date of Event
    August 27, 2007
    Report Date
    September 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 248MG/DL, 163MG/DL, 83MG/DL, AND 76MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT 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 300599

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LANTUS 20 UNITS/DAY - YEARS| HUMALOG 40 UNITS/DAY - YEARS