MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD SYNAPSYS¿ INFORMATICS SOLUTION; CALCULATOR/DATA PROCESSING MODULE

Catalog Number	444150
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd synapsys¿ informatics solution rule 984 did not trigger despite meeting the required criteria.No patient impact reported.
Additional Manufacturer Narrative
This statement is to summarize the investigation of a complaint involving synapsys.It was reported that the rule 984 was not working as expected after pud updated to 7.61.No other issues were reported.Bd investigated the issue.During initial validation following an upgrade to synapsys 6.20 and pud 7.61, it was identified that updated bdxpert rules were not being applied correctly.Specifically, rule 984 did not trigger as expected, resulting in an incorrect antimicrobial interpretation for cefuroxime, where results were interpreted as susceptible (s) instead of intermediate (i) despite meeting rule criteria.The issue was identified during controlled testing prior to full production use.Automatic result uploads were temporarily disabled as a precaution, and no confirmed patient harm occurred.There are no impacted customers currently in the field.The investigation determined that after the pud update, the bdxpert service did not refresh its clips rule files and continued operating with the previous pud rule set.Restarting the bdxpert service on the synapsys server immediately resolved the issue and ensured the updated rules were applied correctly.The issue was detected early during testing at the first installed customer site.As a preventive measure, restarting the bdxpert service was added to the pud installation bulletin and is now included as part of the standard upgrade process.A permanent fix is planned through synapsys code changes targeted for release in version 7.10 and, if applicable, 6.20 sr2.No additional customers were impacted.This issue is caused by a software bug and will be fixed in a future synapsys release.This can be tracked by a system change request.This is a confirmed failure of a bd product.Review found that complaints of this type were under statistical control for the month of november.Device history record review was not applicable as this is a standalone software product, and the operation/functionality of this type of product is confirmed at the time of installation.Reports of this type will continue to be monitored.If you have any additional questions or concerns, please do not hesitate to contact bd technical support.
Event or Problem Description
It was reported that while using bd synapsys¿ informatics solution rule 984 did not trigger despite meeting the required criteria.No patient impact reported.

• Brand Name: BD SYNAPSYS¿ INFORMATICS SOLUTION
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23646721
• Report Number: 1119779-2025-05473
• Device Sequence Number: 9961759
• Product Code: JQP
• UDI-Device Identifier: 00382904441500
• UDI-Public: (01)00382904441500
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 444150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown