BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1003470 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01772
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF 302 MG/DL BACK TO BACK WITH RESULTS OF 144 MG/DL, AND 428 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINS APART. REPORTER INDICATED THAT HE WAS EXPERIENCING SOME HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING AND HE TOOK 4 UNITS OF NOVOLIN R AFTER THE 302 MG/DL RESULT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED FOR THE DISCREPANT BACK TO BACK RESULTS. NO ADVERSE EVENT REPORTED. 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 300771

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR NOVOLIN R - 10 YRS SLIDING SCALE| NOVOLIN 70/30 - 10 YRS 35 UNITS DAILY