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	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd synapsys¿ informatics solution, tests of the previous isolate are being additionally ordered to the next new isolate.No patient impact reported.
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, tests of the previous isolate are being additionally ordered to the next new isolate.No patient impact reported.
Additional Manufacturer Narrative
H.6 investigation summary this statement is to summarize the investigation of a complaint involving synapsys.It was reported that ¿auto increment isolate¿ system setting was not working as expected.No other issues were reported.Bd investigated the issue.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.In cultures with multiple plates, when an isolate is created with auto-ordered organism for one plate, another plate is wrongfully assigned to the test that was associated with auto-ordered organism.This occurs because there was a race condition between ngonchanges and the call back to organism changes.If ngonchanges wins then it wrongfully adds the auto-order test, because the test wasn't yet updated with call back, causing the test from previous test to be added.An additional, erroneous test is added to a plate, incorrectly.The customer will be able to see that the extra test has been added to the plate and have to manually remove it, which will be inconvenient to the user.He evaluation of this bug determined that there is no impact of the anomaly on safety and effectiveness, including operator usage and human factor considerations.Therefore, it is acceptable to remain as an unresolved anomaly present in the software.Review found that complaints of this type were under statistical control for the month of july.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.

• 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: 22686512
• Report Number: 1119779-2025-02201
• Device Sequence Number: 15869009
• 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): Y
• 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): 01/13/2026

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: 07/03/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2018
• 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