BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1123939 · Received August 15, 2008

    Report

    Report Number
    1823260-2008-06264
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    September 14, 2007
    Report Date
    August 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED LOW BLOOD GLUCOSE SYMPTOMS WITH BLOOD GLUCOSE RESULT OF 90 MG/DL OBTAINED ON A PROFESSIONAL DEVICE. CUSTOMER SELF TREATED, AND RE-TESTED WITHIN 10 MINUTES ON THE AVIVA SYSTEM WITH RESULT IN THE 200'S (MG/DL). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER, CUSTOMER NO LONGER HAS THE TEST STRIPS; 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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR NOVOLOG| BAYER ASPIRIN| IRON PILL| LANTUS 65 UNITS IN MORNING