BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿ VIRTUAL SERVER

    MDR report key: 8307256 · Received February 5, 2019

    Report

    Report Number
    1119779-2019-00101
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 8, 2019
    Report Date
    February 18, 2019
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DURING INVESTIGATION OF THE ISSUE, A POSSIBLE DATA ASSOCIATION ERROR IN SYNAPSYS. THIS ERROR MANIFESTED ITSELF IN TWO NOTICEABLE AREAS. READING SCREEN IMAGES OF PLATE ¿ PLATES ASSIGNED TO ONE SPECIMEN HAD A DIFFERENT ACCESSION STAMP ON THE IMAGE (THIS STAMP IS PUT ON THE IMAGE BY THE IMAGING SYSTEM IN BDK). CULTURE SEARCH ¿ WHEN SEARCHING FOR ONE SPECIMEN WITHIN SYNAPSYS BY ACCESSION NUMBER, TWO SPECIMENS WERE RETURNED. DURING INVESTIGATION OF THE CUSTOMER'S DATABASE, THE FOLLOWING WAS DISCOVERED: IT WAS DETERMINED THAT 3 TESTS WERE ASSOCIATED TO BOTH SPECIMENS. THE TEST HIERARCHY FOR THESE TESTS HAD THEM AS CHILDREN TESTS TO A CULTURE PROTOCOL ORDER FOR SPECIMEN ¿A¿ WHILE THE SPECIMEN LINK FOR THE TESTS THEMSELVES POINTED TO SPECIMEN ¿B¿. A QUERY WAS WRITTEN TO FIND ALL INSTANCES OF THIS MIS-ASSOCIATION, AND IT WAS FOUND THAT THERE WERE 5 DISTINCT INSTANCES WHERE THIS MIS-ASSOCIATION HAD OCCURRED. THE LOG ENTRIES ASSOCIATED TO THESE TESTS WERE REVIEWED TO DETERMINE WHAT FEATURES WERE IN USE AT THE TIME OF THE MIS-ASSOCIATION AND THE CIRCUMSTANCES AROUND ERROR. THE LOGS IDENTIFIED THAT THE MANUAL INOCULATION SCREEN IN SYNAPSYS WAS WHERE THE ERROR OCCURRED. A DATABASE CHANGE WAS MADE TO IDENTIFY THE ISSUE OVER DATA RE-ASSOCIATION AND DISALLOW IT ALONG WITH A USER NOTIFICATION THAT THE POTENTIAL DATA RE-ASSOCIATION WAS NOT ALLOWED. THIS CHANGE WAS MADE USING SCR 133223 AND WAS RELEASED IN THE 2.2.2019.01601. THE SYNAPSYS RISK FILE WAS REVIEWED BALTRM-SYNAPSYS-APH. A NEW MITIGATION WAS ADDED AS A RESULT OF THIS COMPLAINT (ID 50) RESULTING IN THE 8F REVISION OF THIS FILE. NO OTHER TRENDS OR NEW HAZARDS WERE IDENTIFIED AS A RESULT OF THE COMPLAINT INVESTIGATION. SA BDDS-19-1446-SA WAS CREATED IN RESPONSE TO THIS COMPLAINT INVESTIGATION. FA BDDS-19-1446-FA HAS ALSO BEEN CREATED IN RESPONSE TO THIS COMPLAINT INVESTIGATION. UPON INVESTIGATION, THE ISSUE WAS CONFIRMED AS AN ISSUE IN SYNAPSYS AND DOCUMENTED IN AN INTERNAL PROBLEM TRACKING TOOL AS SCR 133223. THIS SCR WAS ADDRESSED AND THE RESOLUTION WAS RELEASED IN SYNAPSYS SOFTWARE VERSION 2.2.2019.01601. COMPLAINT CONFIRMED. ROOT CAUSE DETERMINED TO BE USAGE OF THE MANUAL INOCULATION SCREEN AND CULTURE SCANNING/SELECTION AND A COMBINATION OF BROWSER BACK/FORWARD BUTTONS. A CAPA WAS ENTERED AS A RESULT OF FA BDDS-19-1446-FA INDICATING THAT AN CAPA MUST BE AUTOMATICALLY GENERATED.

    Description of Event or Problem · 0

    WHILE THE PATIENT WAS HAVING WHAT WAS BELIEVED TO BE A POSITIVE BLOOD CULTURE SPECIMEN CULTURED ON A PLATE, TWO PATIENT RECORDS STORED ON A BD SYNAPSYS¿ VIRTUAL SERVER BECAME MIS-ASSOCIATED. THE SPECIMEN WAS PROCESSED ON BD KIESTRA¿ INOQULA. AFTER INOCULATION, THE RECORD OF THE SAMPLE BECAME ASSOCIATED WITH THE SAMPLE OF A DIFFERENT PATIENT. THE LAB TECHNICIAN NOTICED THE MIS-ASSOCIATION AND REMOVED THE ERRONEOUS PLATE FROM THE PATIENT RECORD. THE PATIENT'S PLATE WAS LABELLED IN THE LABORATORY INFORMATION SYSTEM AS ¿STAPHYLOCOCCUS SP¿, THE MIS-ASSOCIATED PLATE WAS LABELLED AS AN ANAEROBE. THE PATIENT'S SPECIMEN WAS PROCESSED NORMALLY.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    WHILE THE PATIENT WAS HAVING WHAT WAS BELIEVED TO BE A POSITIVE BLOOD CULTURE SPECIMEN CULTURED ON A PLATE, TWO PATIENT RECORDS STORED ON A BD SYNAPSYS¿ VIRTUAL SERVER BECAME MIS-ASSOCIATED. THE SPECIMEN WAS PROCESSED ON BD KIESTRA¿ INOQULA. AFTER INOCULATION, THE RECORD OF THE SAMPLE BECAME ASSOCIATED WITH THE SAMPLE OF A DIFFERENT PATIENT. THE LAB TECHNICIAN NOTICED THE MIS-ASSOCIATION AND REMOVED THE ERRONEOUS PLATE FROM THE PATIENT RECORD. THE PATIENT'S PLATE WAS LABELLED IN THE LABORATORY INFORMATION SYSTEM AS ¿STAPHYLOCOCCUS SP¿, THE MIS-ASSOCIATED PLATE WAS LABELLED AS AN ANAEROBE. THE PATIENT'S SPECIMEN WAS PROCESSED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101555 BD SYNAPSYS¿ VIRTUAL SERVER DATA MANAGEMENT SYSTEM JQP BECTON, DICKINSON & CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other