BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1171488 · Received September 17, 2008

    Report

    Report Number
    1823260-2008-06939
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 12, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 400 MG/DL BACK TO BACK WITH A RESULT OF 129 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. 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 THE STRIPS USED ARE NO LONGER AVAILABLE, AND SO NO PRODUCT 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 62 YR INSULIN 30 UNITS DAILY| ADVAIR