BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1770592 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09333
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 10, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF 324 MG/DL AND 151 MG/DL BACK TO BACK WITHIN 10 MINUTES WHILE USING THE AVIVA SYSTEM. NO HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS WERE REPORTED BY THE CUSTOMER AND NO ACTION OR TREATMENT RESULTED. 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 300667

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR ASAPHEX - SEVERAL YEARS - 25MG DAILY AM| TORSEMIDE - 40MG AM, 20MG PM| TOPROL - 1-2 MONTHS - 25MG ONCE DAILY| COUMADIN - SEVERAL YEARS - 4 OR 5 MG DAILY PM| DIOVAN - SEVERAL YEARS - 160MG TWICE DAILY| PRAVASTATIN - 2 MONTHS - 25MG ONCE DAILY| TRAMADOL - 2 MONTHS - 50MG DAILY AM| LEVEMIR - 1-5-UNITS SLIDING - BEFORE MEALS| HUMALOG - 3-UNITS DAILY PM