BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1220089 · Received October 31, 2008

    Report

    Report Number
    1823260-2008-08098
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACCU-CHEK AVIVA SYSTEM WITHIN 10 MINUTES: 10MG/DL, 186MG/DL, 196MG/DL, 207MG/DL AND 210MG/DL. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. 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 301315

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR ALLOPURINOL - 2 YEARS| ATENOLOL - 10 YEARS| "COLTHIICINE" - 3 YEARS| "LISFINOPRIL" - 15 YEARS| PREVACID - 15 YEARS| "PYTORIM" - 1 1/2 YEARS| "BUDEPRIONXL" - 3 YEARS| HUMALOG - 8 YEARS| "SYMILIN" - 3 MONTHS| "FEXOFENADINEHCL" - 5 YEARS| "GABAPANTINE" - 10 YEARS| "NABUMTONE" - 4 YEARS| LANTUS - 6 YEARS| AMLODIPINE - 3 MONTHS| "INDAPADANE" - 2 YEARS