BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 12469393 · Received September 14, 2021

    Report

    Report Number
    1119779-2021-01510
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    August 25, 2021
    Report Date
    May 17, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE CUSTOMER REPORTED THAT PATIENT INFORMATION ON THE LIS DID NOT MATCH THE INFORMATION DISPLAYED IN SYNAPSYS MATERIAL NUMBER 444150, SERIAL NUMBER (B)(6). SERVICE CHECKED THE LIS LOGS AND FOUND A MESSAGE WHICH SEEMED TO BE A COMPOSITION OF DIFFERENT MESSAGES. IT WAS DISCOVERED THAT THERE WERE TWO DIFFERENT MESSAGES SENT OVER TWO DIFFERENT MBMS AT THE SAME POINT IN TIME. THESE TWO MESSAGES WERE MIXED TOGETHER AND A SPECIMEN BECAME ASSOCIATED TO THE INCORRECT ACCESSION NUMBER. THIS WAS A CONFIRMED FAILURE OF A BD PRODUCT. THE ROOT CAUSE IS A BUG IN THE CCE- DS ADAPTER WHICH MIXED THE TWO MESSAGES BEFORE SENDING THEM TO SYNAPSYS. THE FIX WILL BE IMPLEMENTED IN THE NEXT VERSION OF CCE-DS ADAPTER WHICH WILL BE AVAILABLE WITH THE NEXT RELEASE OF SYNAPSYS, VERSION 4.20. BD WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ A MISASSOCIATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A SAMPLE WAS REGISTERED UNDER THE WRONG PATIENT IN SYNAPSYS".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ A MISASSOCIATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A SAMPLE WAS REGISTERED UNDER THE WRONG PATIENT IN SYNAPSYS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369304 BD SYNAPSYS¿ NA JQP BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown