BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1033165 · Received April 23, 2008

    Report

    Report Number
    1823260-2008-03464
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    August 15, 2007
    Report Date
    April 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE ACCU-CHEK AVIVA SYSTEM 1. REFERENCE MEDWATCH WITH PT IS FOR SUSPECT DEVICE ACCU-CHEK AVIVA SYSTEM 2.

    Description of Event or Problem · 1

    THE REPORTER STATES THAT HE OBTAINED THE BLOOD GLUCOSE RESULT OF 300MG/DL ON ACCU-CHEK AVIVA SYSTEM 1 IN COMPARISON TO THE BLOOD GLUCOSE RESULT OF 130MG/DL ON ACCU-CHEK AVIVA SYSTEM 2. THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. NO REPORTED ACTIONS 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR METFORMIN - 2000MG/DAY| LANTUS - 90 UNITS/DAY