BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA

    MDR report key: 1002633 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01363
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    April 22, 2007
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER INQUIRIES EVALUATED THE RETURNED AVIVA SYSTEM AND DISCOVERED A DISPLAY ISSUE, WHERE A SEGMENT WAS MISSING FROM THE NUMBER RESULT FIELD. THE CUSTOMER WAS UNAWARE OF THE ALLEGED DISPLAY ISSUE, WHEN HE CALLED THE MANUFACTURER. NO ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT REPORTED. THE SUSPECT DEVICE WAS ALREADY RETURNED AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA BLOOD GLUCOSE MONITORING DEVICE NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK