BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1170726 · Received September 15, 2008

    Report

    Report Number
    1823260-2008-06882
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    September 7, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 78 MG/DL BACK TO BACK WITH A RESULT OF 200 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT HE WAS FEELING HYPOGLYCEMIC SYMPTOMS WHEN THE 78 MG/DL RESULT WAS OBTAINED. REPORTER STATED THAT HE SELF-TREATED WITH ORANGE JUICE BEFORE THE 200 MG/DL RESULT WAS OBTAINED. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 301115

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LANTUS - 40 UNITS DAILY| NOVOLOG - SLIDING SCALE