BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1761041 · Received July 19, 2007

    Report

    Report Number
    1823260-2007-06330
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    June 23, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF 597 MG/DL BACK TO BACK WITH A RESULT OF 114 MG/DL WHEN TESTING WAS PERFORMED 3 MINUTES APART ON THE AVIVA SYSTEM. REPORTER STATED, HE WAS NOT EXPERIENCING ANY HYPERGLYCEMIC SYMPTOMS AFTER THE FIRST TEST AND HAD NO HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS AFTER THE SECOND RESULT WAS TAKEN. NO REPORT OR ACTIONS TAKEN OR TREATMENT RECEIVED. 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 300598

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR DAILY MULTIVITAMINS - 2 YRS - ONCE DAILY| METFORMIN - 2 WKS - 500 MG TWICE DAILY| VITAMIN C - 500 MG ONCE DAILY| VITAMIN E - 400 IU ONCE DAILY| HYDROCHLOROTHIAZIDE - AS OF 6-13 - 25MG ONCE DAILY| ARMOUR - 2 WKS - 30 MG TWICE DAILY