BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1045163 · Received May 13, 2008

    Report

    Report Number
    1823260-2008-03965
    Event Type
    Malfunction
    Date Received
    May 13, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE CUSTOMER EXPERIENCED A HYPERGLYCEMIC EVENT WHERE HE WS TAKEN TO THE ER. THE CUSTOMER'S BLOOD GLUCOSE RESULTS WERE IN THE 200'S (MG/DL), 300'S (MG/DL) AND 400'S (MG/DL) PRIOR TO EVENT. AT THE HOSP, THE CUSTOMER HAD A BLOOD GLUCOSE RESULT IN THE 400-500'S (MG/DL) ON THE ACCU-CHEK AVIVA SYSTEM IN COMPARISON TO THE PROFESSIONAL METER RESULT IN THE 200'S (MG/DL). THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. THE CUSTOMER WAS EXPERIENCING KETOACIDOSIS AND WAS TREATED WITH AN IV (UNK CONTENTS). NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNK TYPE INHALER - 1-2X/TR| MOTRIN UNK DOSE - SOMETIMES| LANTUS 80 MG/DAY| NOVOLOG 1 UNIT PER 5