BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1040986 · Received May 8, 2008

    Report

    Report Number
    1823260-2008-03858
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 446 MG/DL, 333 MG/DL AND 160 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. REPORTER STATED HE TOOK HIS NORMAL 500 MG OF METFORMIN AND ATE BREAKFAST AFTER OBTAINING THE READINGS. 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 PROD 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 300989

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR ADVANDIA - NO LONGER ON| METFORMIN - UNK MONTHS 500 MG