BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 15126673 · Received July 28, 2022

    Report

    Report Number
    1119779-2022-01041
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    July 4, 2022
    Report Date
    January 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    UDI-DI
    03829044415010
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS WAS LOGGED AGAINST SYNAPSYS MATERIAL #(B)(4), SERIAL # (B)(6). BD INVESTIGATED THE ISSUE. WHEN THE BD INOQULA SOFTWARE CRASHES, THE PLATES ARE PRODUCED BUT HAVE NOT BEEN PROCESSED THAT ARE STILL ON THE INSTRUMENT. THE USER EXPECTS TO BE ABLE TO MANUALLY INOCULATE THESE ERRORED PLATES IN SYNAPSYS. SYNAPSYS DOES NOT HAVE ORDERS PENDING. THE PLATES SHOULD BE PROCESSED IN THE INOQULA AS THESE PLATES ARE WAITING TO BE PRODUCED. NO PATIENT TREATMENT WAS IMPACTED. SYNAPSYS AND KIESTRA IS WORKING AS DESIGNED. AN ENHANCEMENT REQUEST WAS APPROVED TO FIX THIS CUSTOMER ISSUE AND WILL BE FIXED IN A FUTURE SYNAPSYS RELEASE. THIS IS A CONFIRMED FAILURE OF A BD PRODUCT. DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED FOR STAND ALONE SOFTWARE. SOFTWARE OPERATION (OR FUNCTIONALITY) IS CONFIRMED AT TIME OF INSTALLATION. BD WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS ISSUE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THE CULTURE WORKUP WORKFLOW WAS NOT FUNCTIONING PROPERLY. THIS IS A REPORT OF A SINGLE OCCURRENCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE PERFORMS RUN ON INOQULA INOQULA SOFTWARE CRASHES. (KIESTRA DELETES PRODUCED BUT UNPROCESSED PLATES) INOCULATES SAMPLES TAKEN TO SYNAPSYS UI - INOCULATION MODE SYNAPSYS UI SHOWS NO ORDERS PENDING IF SAMPLES TAKEN TO INOQULA DELETED PLATES AND UNPROCESSED PLATES WAITING TO BE REPRODUCED. CAUSE OF ISSUE: AFTER AN ISSUE ON INOQULA FA, USER HAVE PURGE THE SYSTEM AS REQUESTED BY INSTRUMENT. HE TRIED TO FINISH THE SAMPLE NOT DONE IN MANUAL INOCULATION IN SYNAPSYS. HOWEVER, THE PLATES WERE NOT PRESENT IN SYNAPSYS. TO BE ABLE TO DO THE SAMPLE, HE HAD TO USE INOQULA (FA OR SA). ON BATCH PREPARATION OF SA, WE COULD SEE THE 3 (MISSING IN SYNAPSYS) PLATES ¿DELETED¿ AND ONLY ¿REQUESTED¿ WHEN STARTING THE BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ THE CULTURE WORKUP WORKFLOW WAS NOT FUNCTIONING PROPERLY. THIS IS A REPORT OF A SINGLE OCCURRENCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE PERFORMS RUN ON INOQULA INOQULA SOFTWARE CRASHES. (KIESTRA DELETES PRODUCED BUT UNPROCESSED PLATES) INOCULATES SAMPLES TAKEN TO SYNAPSYS UI - INOCULATION MODE SYNAPSYS UI SHOWS NO ORDERS PENDING IF SAMPLES TAKEN TO INOQULA DELETED PLATES AND UNPROCESSED PLATES WAITING TO BE REPRODUCED. CAUSE OF ISSUE: AFTER AN ISSUE ON INOQULA FA, USER HAVE PURGE THE SYSTEM AS REQUESTED BY INSTRUMENT. HE TRIED TO FINISH THE SAMPLE NOT DONE IN MANUAL INOCULATION IN SYNAPSYS. HOWEVER, THE PLATES WERE NOT PRESENT IN SYNAPSYS. TO BE ABLE TO DO THE SAMPLE, HE HAD TO USE INOQULA (FA OR SA). ON BATCH PREPARATION OF SA, WE COULD SEE THE 3 (MISSING IN SYNAPSYS) PLATES ¿DELETED¿ AND ONLY ¿REQUESTED¿ WHEN STARTING THE BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440672 BD SYNAPSYS¿ NA JQP BECTON, DICKINSON & CO. (SPARKS) 03829044415010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown