BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1080533 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05629
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 14, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS RESULTS OF 200-300 MG/DL ON THE AVIVA SYSTEM, WHILE A COMPARISON LAB AND PROFESSIONAL DEVICE RETURNED AS 110-120 MG/DL WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE 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 300740

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK