BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NBCS-NATIONAL BIOMEDICAL COMPUTER SYSTEM

    MDR report key: 370741 · Received January 8, 2002

    Report

    Report Number
    1124939-2002-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2002
    Date of Event
    December 10, 2001
    Report Date
    January 8, 2002
    Manufacturer
    AMERICAN NATIONAL RED CROSS
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A PROBLEM WITH THE NATIONAL BIOMEDICAL COMPUTER SYSTEM (NBCS) POTENTIAL MATCH REPORT IDENTIFIED AS HAVING BEEN INTRODUCED IN VERSION 1.5.0. THE POTENTIAL MATCH REPORT FUNCTIONALITY WAS FIRST INTRODUCED WITH THE RELEASE OF NBCS VERSION 1.4.6A BUT NBCS VERSIONS EARLIER THAN 1.5.0 ARE NOT AFFECTED BY THIS PROBLEM. THE PROBLEM WITH NBCS VERSION 1.5.0 WAS FIRST DISCOVERED IN EARLY DECEMBER 2001 WHILE PERFORMING REGRESSION TESTING OF NBCS 1.5.1 DURING THE DEVELOPMENT PHASE OF THAT SOFTWARE PATCH, SIP 1630. THIS SIP, WHICH WAS INTENDED TO FIX A DIFFERENT SOFTWARE PROBLEM, WAS FIRST APPLIED TO NBCS 1.5.0 AS INDICATED ABOVE, THE PROBLEM WITH VERSION 1.5.0 WAS NOT IDENTIFIED UNTIL THE NBCS 1.5.1 DEVELOPMENT PHASE TESTING HAD OCCURRED. IN 2001, A POTENTIAL HAZARD MEETING WAS HELD TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NBCS-NATIONAL BIOMEDICAL COMPUTER SYSTEM SOFTWARE, BLOOD-BANK (STAND ALONE PRODUCTS) MMH AMERICAN NATIONAL RED CROSS NA 1.5.0

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other