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

Catalog Number 444150

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2023

Event Type  Injury  

Event Description

It was reported that during use with the bd synapsys¿, a false negative result was obtained.The patient's treatment was stopped due to the false result.Confirmatory testing was performed and the result was positive.The following information was provided by the initial reporter: hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details customer reports that a negative result has been reported for a blood culture patient sample when in fact it should have been positive (instrument result was positive).The negative result was sent too soon to the lis system.Patient antibiotics were stopped due to the negative result received.Confirmatory testing showed that the bottle was positive.No death reported.There has been an incident in which a negative result has been sent for a bottle from synapsys to the customers lis for a bottle which actually was positive.The customer mentions that possibly some filters are incorrectly set up in synapsys which have resulted in this.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use with the bd synapsys¿, a false negative result was obtained.The patient's treatment was stopped due to the false result.Confirmatory testing was performed and the result was positive.The following information was provided by the initial reporter: hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details customer reports that a negative result has been reported for a blood culture patient sample when in fact it should have been positive (instrument result was positive).The negative result was sent too soon to the lis system.Patient antibiotics were stopped due to the negative result received.Confirmatory testing showed that the bottle was positive.No death reported.There has been an incident in which a negative result has been sent for a bottle from synapsys to the customers lis for a bottle which actually was positive.The customer mentions that possibly some filters are incorrectly set up in synapsys which have resulted in this.

Manufacturer Narrative

H.6 investigation summary: this statement is to summarize the investigation of a complaint involving bd synapsys.According to information provided, the customer reported that false negative results were sent to lims.No other issues were reported.During investigation, bd service personnel investigated the issue.Bd remoted in and found that this was caused by the customer lis.The issue was raised with the lis company and an lis patch was applied.The issue is resolved.This was an unconfirmed failure of a bd product.Synapsys worked as designed.Review found complaints of this type were under statistical control for the month of may.Additionally, no adverse trend was identified for reports of this type.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.However, as there is no evidence of any new adverse trend, hazard or risk, no additional action is currently indicated.If you have any additional questions or concerns, please do not hesitate to contact bd technical support.

• Brand Name: BD SYNAPSYS¿
• Type of Device: 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: 17121180
• MDR Text Key: 317112315
• Report Number: 1119779-2023-00646
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 444150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention