BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1761306 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06361
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    July 2, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE VALUES OF 10MG/DL BACK TO BACK WITH A RESULT OF 127MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS WERE TAKEN OR TREATMENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 300353

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HCTZ - 2MOS - 125MILIGRAMS ONCE DAILY| LEVOTHYROXINE - 8-9YRS - 0.25MILIGRAMS ONCE DAILY| ATENOLOL - 2YRS - 0.25MILIGRAMS ONCE DAILY