BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELAN VESMATIC 20

    MDR report key: 354509 · Received October 2, 2001

    Report

    Report Number
    MW1022986
    Event Type
    Malfunction
    Date Received
    October 2, 2001
    Date of Event
    October 2, 2001
    Report Date
    October 2, 2001
    Manufacturer
    *
    Product Code
    GKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS YEAR THE CO CONTACTED ELAN REGARDING THE VESMATIC INTERFACE WITH THE SUNQUEST LIS SYSTEM. ELAN PERFORMED SOFTWARE UPDATES THAT NEEDED TO BE RECONFIGURED IN SUNQUEST. ELAN WAS NOT ABLE TO PROVIDE THE NEEDED DOCUMENTATION THAT DESCRIBED THE SOFTWARE CHANGES. THE CO LEARNED THAT IN FACT ELAN PERFORMED MULTIPLE SOFTWARE CHANGES WITHOUT NOTIFYING CUSTOMERS AND PROVIDING THE NEEDED DOCUMENTATION. SUNQUEST REFUSED TO UPDATE THE INSTRUMENT INTERFACE, AND NOW THE CO CAN NO LONGER AUTO TRANSMIT SED RATE RESULTS. ELAN WAS NEGLIGENT IN NOT MAKING ITS CUSTOMERS AWARE OF THE SOFTWARE CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44488 ELAN VESMATIC 20 AUTOMATED SED RATE ANALYZER GKB * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *