BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1001766 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01657
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 10, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF HI (GREATER THAN 600 MG/DL), 114 MG/DL AND 165 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER INDICATED THAT HE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO 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 300690

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR "ASPART L CLEAR" - SLIDING SCALE| PYRIDOXINE HCL - 50 MG 1/2 TAB 3 TIMES DAILY| "NPH N CLOUDY" - 10 UNITS DAILY| FUROSEMIDE - 80 MG DAILY| CYANOCOBALAMIN - 500 MCG DAILY| HYDROCODONE - 5/500 1-2 TABS AS NEEDED| "ROSURASTATIN CA" - 10 MG 1.2 TAB NIGHTLY| TRAMADOL - 50 MG AS NEEDED| ROPINIROLE HCL - 1 MG 1/2 TAB 3 TIMES DAILY| GABAPENTIN - 300 MG 2 TABS 3 TIMES DAILY| EZETIMIBE - 10 MG NIGHTLY| CITALOPRAM HYDROBROMIDE - 20 MG DAILY| "NPH N CLOUDY" - 20 UNITS NIGHTLY| WARFARIN - 4 MG 1-1.5 TABS NIGHTLY| LOSARTAN - 50 MG DAILY| METOPROLOL TARTRATE - 50 MG DAILY| FLUNISOLIDE - 25 MCG TWICE DAILY