BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1470518 · Received June 8, 2009

    Report

    Report Number
    1823260-2009-04013
    Event Type
    Malfunction
    Date Received
    June 8, 2009
    Date of Event
    May 25, 2009
    Report Date
    June 8, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 500 MG/DL BACK TO BACK WITH A RESULT OF 170-175 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED HE TOOK 12 UNITS OF HUMULIN R BASED ON THE 170-175 MG/DL RESULT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. REPORTER STATED, HE NO LONGER HAS THE STRIPS AND SO, NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 65 YR METHOTREXATE - 5 YEARS| ENALAPRIL - 10 YEARS| HUMULIN R - 20 YEARS| REMICADE - 1 YEAR