MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD SYNAPSYS¿; BD SYNAPSYS LABORATORY SOLUTIONS

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	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using using bd synapsys¿ there was an application error that caused changes to the blood culture protocol time.This is a report of one occurrence, and no patient impact.
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.E1: initial reporter phone (b)(6).
Additional Manufacturer Narrative
Investigation summary: this statement is to summarize the investigation of a complaint involving synapsys.It was reported synapsys was having issues with blood culture protocol times changing.No other issues were reported.Bd investigate the issue.Rule 8 should change the protocol time to 10 days, but the protocol time was changed back to 5 days.The lab was able to pick up this problem and put them back again on a new 5-day protocol.The customer was recommended to disable this rule and changed protocol times directly on fx.The instrument adapter was crashing from the system event logs.The dataupdate service was not sending anything to the instruments.The instrument adapter service was not crashing after 27th of february.The fx versions was updated.It was found that the fx versions were found to be running an older version.Capa will address this 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.Review found complaints of this type were below statistical control for the month of january.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.
Event or Problem Description
It was reported that while using using bd synapsys¿ there was an application error that caused changes to the blood culture protocol time.This is a report of one occurrence, and no patient impact.

• Brand Name: BD SYNAPSYS¿
• Common Device Name: BD SYNAPSYS LABORATORY SOLUTIONS
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18652783
• Report Number: 1119779-2024-00079
• Device Sequence Number: 7084210
• Product Code: JQP
• UDI-Device Identifier: 00382904441500
• UDI-Public: 00382904441500
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• 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): 06/28/2024

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: 01/09/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2020
• 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