BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 16627947 · Received March 28, 2023

    Report

    Report Number
    1119779-2023-00331
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    February 20, 2023
    Report Date
    May 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    GWN
    UDI-DI
    00382904441500
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED A SYNAPSES ISSUE WHERE, WHEN THEY CLICK "MARK AS READ" AND A NEW CULTURE POPS UP, 5-10 SECONDS GO BY BEFORE THE NEW ACCESSION NUMBER AND PLATE DEMOGRAPHICS SHOW UP. THIS WAS RECORDED AGAINST SYNAPSES, MATERIAL NUMBER 444150, SERIAL NUMBER SL00005. THIS WAS DETERMINED TO BE A BUG IN SYNAPSES WHERE THERE IS A BUG IN SYNAPSES WHICH CAN RESULT IN AN ASYNCHRONOUS LOADING BETWEEN THE CULTURE IMAGES AND THE PATIENT AND SPECIMEN INFORMATION PANEL. A CORRECTIVE AND PREVENTATIVE ACTION WAS OPENED TO INVESTIGATE THE ROOT CAUSE OF THIS PROBLEM. IN THIS CASE, THE CUSTOMER REPORTED THE INCORRECT INFORMATION TO THEIR LIS. THIS IS A CONFIRMED FAILURE OF A BD PRODUCT, THE ROOT CAUSE IS A BUG IN SYNAPSES. SERVICE UPDATED THE CUSTOMER TO THE LATEST VERSION OF SYNAPSES AND PERFORMED A DATABASE PURGE TO FREE UP RESOURCES AND MINIMIZE THE CHANCE FOR THIS DELAY IN LOADING. BD WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS ISSUE. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT BD SYNAPSES¿ A SLOWNESS OF ACCESSION NUMBERS POPULATING IS NEGATIVELY AFFECTING PATIENT RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS SYNAPSES ISSUE THAT AN ISSUE WHERE WHEN THEY CLICK MARK AS READ AND A NEW CULTURE POPS UP THE PLATES SHOW UP, THEN 5-10 SECONDS GO BY BEFORE THE NEW CID AND PATIENT DEMOS SHOW UP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYNAPSYS¿ A SLOWNESS OF ACCESSION NUMBERS POPULATING IS NEGATIVELY AFFECTING PATIENT RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS SYNAPSYS ISSUE THAT AN ISSUE WHERE WHEN THEY CLICK MARK AS READ AND A NEW CULTURE POPS UP THE PLATES SHOW UP, THEN 5-10 SECONDS GO BY BEFORE THE NEW CID AND PATIENT DEMOS SHOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13192 BD SYNAPSYS¿ NA GWN BECTON, DICKINSON & CO. (SPARKS) 00382904441500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown