MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD SYNAPSYS¿ INFORMATICS SOLUTION; UNKNOWN

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	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2a.Common device name: unknown.H3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H4.Device manufacture date: unknown.
Event or Problem Description
It was reported that while using bd synapsys¿, there was misassociation seen with multiple samples.No patient impact reported.
Additional Manufacturer Narrative
Investigation summary: this statement is to summarize the investigation of a complaint involving synapsys.It was reported that synapsys was sending multiple results per sample.No other issues were reported.Bd investigated the issue.The lis is getting duplicate whole result messages.The issue at this site was user configuration.The customer has duplicate rules triggering upload of results to the lis multiple times.The user can adjust the rules to prevent this from occurring.Synapsys works as designed.This is an unconfirmed failure of a bd product.Review found complaints of this type were below statistical control for the month of march.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 bd synapsys¿, there was misassociation seen with multiple samples.No patient impact reported.

• Brand Name: BD SYNAPSYS¿ INFORMATICS SOLUTION
• Common Device Name: UNKNOWN
• 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: 19116002
• Report Number: 1119779-2024-00294
• Device Sequence Number: 7112487
• Product Code: JQP
• UDI-Device Identifier: 00382904441500
• UDI-Public: 00382904441500
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• 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: Health Professional
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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