BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1070504 · Received July 7, 2008

    Report

    Report Number
    1823260-2008-05233
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 29, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 230 MG/DL, 120 MG/DL AND 133 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT 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 301072

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR LIPITOR - 80MG DAILY| ZETIA - 10MG DAILY| FLOVENT - 2 PUFFS TWICE DAILY AS NEEDED| DICLOFENAC - 75MG TWICE DAILY| AVANDIA - 4MG DAILY| THEOPHYLLINE - 300MG TWICE DAILY| BUPROPION - 150MG TWICE DAILY| COMBIVENT - 2 PUFFS TWICE DAILY AS NEEDED| CALCIUM - 600MG DAILY| SERTRALINE - 200MG DAILY