BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1082622 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05690
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 143 MG/DL, 175 MG/DL AND 360 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER INDICATED THAT HE WAS EXPERIENCING SOME HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER STATED HE SLEPT TO TREAT HIMSELF. NO OTHER ACTIONS WERE REPORTEDLY 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 300577

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR NIACIN - 3 YEARS - 500MG 4 TIMES DAILY| TRAZODONE - 3 YEARS| ACTOS MET - 6 MONTHS - 1 TAB 3 TIMES DAILY| AMARYL - 6 MONTHS - 0.5 TAB TWICE DAILY| "NORZIPAN" - 3 YEARS - 1MG 3 TIMES DAILY| SEROQUEL - 1 MONTH - 50MG DAILY