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

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	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.E1.Initial reporter facility name: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H4.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use with the bd synapsys¿, patient data was associated to the incorrect patient.There was no report of patient impact.The following information was provided by the initial reporter: mrsa result associated with incorrect lab number.
Additional Manufacturer Narrative
H.6.Investigation summary: this statement is to summarize the investigation of a complaint involving synapsys.According to information provided, the customer reported there was a delayed demographics issue where incorrect results were logged under the incorrect lab number.No other issues were reported.During investigation, bd service personnel investigated the issue.When the kiestra scu server is under very heavy load, a delay in loading the demographics data may occur after the culture plates are displayed to the user (this customer reported a delay of up to 10 seconds).This is issue was caused by a software bug and will be fixed in a future release.The system was updated with the synapsys patch containing the fix.This was a confirmed failure of a bd product.Based on the results of this investigation, this case has been assessed as confirmed bd quality issue.Device history record review was not applicable in this case as this is a standalone software product and the operation/ functionality of this type of product is confirmed at the time of installation.
Event or Problem Description
It was reported that during use with the bd synapsys¿, patient data was associated to the incorrect patient.There was no report of patient impact.The following information was provided by the initial reporter: mrsa result associated with incorrect lab number.

• Brand Name: BD SYNAPSYS¿
• Common Device Name: NA
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17289185
• Report Number: 1119779-2023-00747
• Device Sequence Number: 6347679
• Product Code: JQP
• UDI-Device Identifier: 00382904441500
• UDI-Public: 382904441500
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/12/2023

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: 06/14/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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