BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NBCS-NATIONAL BIOMEDICAL COMPUTER SYSTEM

    MDR report key: 320030 · Received March 9, 2001

    Report

    Report Number
    1124939-2001-00002
    Event Type
    Malfunction
    Date Received
    March 9, 2001
    Date of Event
    February 8, 2001
    Report Date
    March 9, 2001
    Manufacturer
    AMERICAN NATIONAL RED CROSS
    Product Code
    MMH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION OF THE EVENT: DURING A REVIEW IN 2001 OF A USER REQUEST FOR GUIDANCE, THE AMERICAN RED CROSS DISCOVERED A PROBLEM IN THE NATIONAL BIOMEDICAL COMPUTER SYSTEM (NBCS). THE ALABAMA REGION REPORTED RECEIVING A REPORT THAT CONTAINS THE CORRECT HEADER AND COLUMN HEADERS BUT NO DATA FROM THE DDR QUERY IN DONOR CORE MODULE OF NBCS WHEN THE STAFF MEMBER PERFORMED THE QUERY USING A DONOR LAST NAME THAT CONTAINED AN APOSTROPHE. THE DDR QUERY IS USED TO SCREEN DONOR NAMES AGAINST THE NATIONAL DONOR DEFERRAL REGISTRY (NDDR) WHEN THERE IS A CHANGE IN THE DONOR NAME, BIRTHDATE, OR SSN. THE DDR QUERY CAN BE PERFORMED BY ENTERING EITHER THE DONOR SSN OR THE LAST NAME AND DATE OF BIRTH. THE REPORT NORMALLY LISTS THE NAMES AND SSN OF "POTENTIAL HITS" IN THE NDDR OR CONTAINS THE MESSAGE, "NO POTENTIAL MATCHES FOUND ON THE NATIONAL DDR". POTENTIAL HITS ARE DONOR NAMES FROM OTHER FACILITIES THAT ARE SAME OR SIMILAR TO THE DONOR NAME OR SSN THAT WAS ENTERED INTO THE QUERY. THE REGIONAL STAFF THEN PERFORMS THE INVESTIGATION TO DETERMININE IF THERE IS A "TRUE HIT". INVESTIGATION FOUND THAT WHEN A LAST NAME THAT CONTAINS AN APOSTROPHE IS SCREENED USING THE DDR QUERY IN DONOR CORE THE QUERY ABNORMALLY TERMINATES. THE ABNORMAL TERMINATION RESULTS IN THE DONOR NAME NOT BEING SCREENED AGAINST THE NDDR AND A REPORT THAT CONTAINS THE CORRECT HEADER AND COLUMN HEADERS BUT NO DATA (NAMES OR MESSAGES). USERS MAY EQUATE A BLANK REPORT WITH NO POTENTIAL HITS ON THE NDDR. IF THE DONOR IS SCREENED UTILIZING THE SSN THE DDR QUERY IN DONOR CORE THE GUQERY PERFORMS CORRECTLY. ARC IS NOT AWARE OF ANY PRODUCTS AT THIS TIME THAT HAVE BEEN ADVERSELY AFFECTED BY THIS SITUATION. THERE HAVE BEEN NO REPORTS OF ADVERSE EFFECTS FROM THIS SITUATION TO DATE. IN THE SPIRIT OF COMPLIANCE WITH THE MEDICAL DEVICE REGULATIONS WERE SUBMITTING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10352 NBCS-NATIONAL BIOMEDICAL COMPUTER SYSTEM SOFTWARE, BLOOD BANK (STAND ALONE PRODUCT) MMH AMERICAN NATIONAL RED CROSS NA VERSION 1.4.5.A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other