BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1770671 · Received October 29, 2007

    Report

    Report Number
    1823260-2007-09407
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    October 12, 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
    OR, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULT OF 580 MG/DL BACK TO BACK WITH A RESULT OF 104 MG/DL WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART ON THE AVIVA 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 300813

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR HCTZ - 2 YEARS - 25MG ONCE DAILY| LISINOPRIL - 2 YEARS - 40MG TWICE DAILY| METFORMIN - 2 YEARS - 1000MG TWICE DAILY| CYMBALTA - 2 YEARS - 60MG AS NEEDED| ASPIRIN - 2 YEARS - 81MG ONCE DAILY| NOVOLIN - 1 YEAR - 80 UNITS DAILY| AMLODIPINE - 2 YEARS - 10MG ONCE DAILY| TOPROL - 2 YEARS - 1000MG ONCE DAILY| GLYBURIDE - 2 YEARS - 5MG TWICE DAILY| LIPITOR - 2 YEARS - 20MG ONCE DAILY