BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NBCS (NATIONAL BIOMEDICAL COMPUTER SYSTEM)

    MDR report key: 271526 · Received March 29, 2000

    Report

    Report Number
    1124939-2000-00002
    Event Type
    Malfunction
    Date Received
    March 29, 2000
    Date of Event
    December 15, 1999
    Report Date
    March 28, 2000
    Manufacturer
    AMERICAN NATIONAL RED CROSS
    Product Code
    MMH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ON DECEMBER 17, 1999, THE USER FACILITY REPORTED (CLARIFY CASE NO. 164469) THAT THE NBCS SYSTEM HAD AUTOMATICALLY REMOVED A "NOTF" ASSERTION FROM A DONOR RECORD BEFORE THE APPROPRIATE END DATE OF THE ASSERTION. THE NBCS SYSTEM AUTOMATICALLY APPLIES A "NOTF" ASSERTION TO A DONOR RECORD WHEN APPROPRIATE. THE "NOTF" ASSERTION TRIGGERS THE PRINTING OF CERTAIN DONOR NOTIFICATION LETTERS AND TEST RESULTS AND SHOULD REMAIN ON A DONOR'S RECORD FOR 30 DAYS. ON DECEMBER 15, 1999, THE SYSTEM PROPERLY APPLIED THE NOTF ASSERTION TO FOUR DONOR RECORDS. HOWEVER, THE SYSTEM NEVER GENERATED THE NOTIFICATION LETTERS. WHEN THE REGION REVIEWED THE DE-ASSERTION LOG, IT NOTED THAT ALL FOUR ASSERTIONS HAD A START DATE OF 12/15/1999 AND END DATE OF 01/14/1900. THE NOTF ASSERTION HAD BEEN PREMATURELY REMOVED FROM THESE FOUR RECORDS.

    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 VERSION 1.4.1

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other