BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1770658 · Received October 29, 2007

    Report

    Report Number
    1823260-2007-09413
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    October 13, 2007
    Report Date
    October 29, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE VALUES OF 160 MG/DL BACK TO BACK WITH A RESULT OF ABOUT 76 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED AT A DIFFERENT TIME OTHER COMPARATIVE TESTS OF 200 MG/DL AND 83 MG/DL WERE PERFORMED BACK TO BACK WITHIN 10 MINUTES ON THE SAME SYSTEM. REPORTER INDICATED HE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 300610

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR LOTREL - 8 YEARS - ONCE DAILY| ZIAC - 8 YEARS - 25MG TWICE DAILY| HUMULIN N - 4 YEARS - 65 UNITS DAILY