BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1181587 · Received September 25, 2008

    Report

    Report Number
    1823260-2008-07182
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 5, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS .
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF H1 (GREATER THAN 600 MG/DL) BACK TO BACK WITH A RESULT OF 178 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND THE CUSTOMER DECLINED THE REPLACEMENT PRODUCT BEING SENT. REPORTER STATED SHE NO LONGER HAS THE STRIPS 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 61 YR INSULIN PUMP - 10 YEARS