BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1772000 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08169
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    August 25, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF 167 MG/DL BACK-TO-BACK WITH A RESULT OF 64 MG/DL WHEN TESTING WAS PERFORMED 10 MINUTES APART ON THE AVIVA SYSTEM. REPORTER STATED HE WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING AND SELF-TREATED WITH FRUIT AND A COOKIE. NO OTHER 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 300652

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR DIGOXIN - 2YRS, 1.25 MG/ONCE DAILY| ACTOS/METFORMIN - 3MOS, 15/850MG/TWICE DAILY| TAZTIA - 3 YRS, 120MG/ONCE DAILY| DIOVAN - 6MOS, 80MG/ONCE DAILY| METOPROLOL - 3 YRS, 50MG/TWICE DAILY| GLIMEPIRIDE - 3 MOS, 4MG/ONCE DAILY| LEVEMIR - 2MOS, 8UNITS/ONCE DAILY| ASPIRIN - 2YRS, 325MG/ONCE DAILY