BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1052044 · Received May 21, 2008

    Report

    Report Number
    1823260-2008-04191
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    December 27, 2007
    Report Date
    May 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK TO BLOOD GLUCOSE RESULTS OF 437 MG/DL, 221 MG/DL, 180 MG/DL AND 111 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER STATED THAT SHE SELF-TREATED BY DRINKING WATER AND EXERCISING. 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. REPORTER STATED THAT SHE NO LONGER HAS THE STRIPS USED AND SO NOTHING WILL BE RETURNED FOR EVALUATION.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR METFORMIN - 1 YEAR| LANTUS - 1 YEAR - 45 UNITS ONCE NIGHTLY