BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFENSE BLOOD STANDARD SYSTEM

    MDR report key: 736033 · Received July 20, 2005

    Report

    Report Number
    1119523-2005-00003
    Event Type
    Malfunction
    Date Received
    July 20, 2005
    Date of Event
    December 15, 2004
    Report Date
    July 15, 2005
    Manufacturer
    DOD/DMLSS/PROJECT OFFICE
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHMENT #1: DTB 05-13. ATTACHMENT #2: DBO 2619. A SCRIPT IS BEING DEVELOPED TO ADDRESS SITUATIONS WHERE A FAILED UPLOAD HAS ALREADY OCCURRED AND HAS GONE UNDETECTED AND TO FIX POST-MERGE PERSON RECORDS THAT COULD POTENTIALL REPRODUCE THE UPLOAD PROBLEM. THIS SCRIPT WILL ALSO ELIMINATE THE NEED TO CONTINUE USING THE WORKAROUND PROVIDED IN THIS DTB. ONCE THE SCRIPT IS AVAILABLE THIS DTB WILL BE UPDATED NOTIFYING USERS. A TROUBLE TICKET WILL NEED TO BE OPENED WITH THE MHS HELP DESK FOR AN INVESTIGATION TO BE PERFORMED TO DETERMINE IF A DATAMOD IS REQUIRED TO CORRECT PROBLEMS THAT ARE ALREADY IN YOUR SYSTEM.

    Description of Event or Problem · 1

    UPON UPLOAD TO THE IN-HOUSE SERVER, DBSS FAILS TO ASSIGN A NEW MOBILE DONOR REGISTRATION, PHLEBOTOMY AND UNIT INFORMATION TO THE ACTIVE RECORD ON THE SERVER. THIS PROBLEM ONLY OCCURS IN CASES WHERE THE DONOR WAS PART OF A PERSON MERGE PRIOR TO THE MOBILE DOWNLOAD/UPLOAD PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFENSE BLOOD STANDARD SYSTEM BLOOD ESTABLISHMENT COMPUTER SOFTWARE MMH DOD/DMLSS/PROJECT OFFICE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other