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

Catalog Number 444150

Device Problem Non Reproducible Results (4029)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

It was reported that while using bd synapsys¿ that there was incorrect data.The following information was provided by the initial reporter: wed aug 30 14:18:48 utc 2023 - patient fields updated: hazard, injury or erroneous results? yes hazard, injury or erroneous results details mismatch between 1 result in synapsys and what lis called out.Rootcause unclear yet.Sample nr (b)(6).In synapsys the result is (partially positive), in screen it the following result is stated: client already informed; destroy zas.[sic] this does not match.

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: this statement is to summarize the investigation of a complaint involving synapsys.According to information provided, one result from synapsys does not match their lis.No other issues were reported.During investigation, bd service personnel investigated the issue.Bd remoted in and determined that the issue was on the customer¿s lis.There was no impact to the patient.This was an unconfirmed failure of a bd product.Review found complaints of this type were under statistical control for the month of august.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.H3 other text : see h.10.

Event Description

Please clarify - is the customer alleging that syn did not send any results to the lis or that the syn system sent incorrect results? if the customer is stating that incorrect results were transmitted, please clarify what impact this had to patients (if any).Response:it was reported that while using bd synapsys¿ that there was incorrect data.The following information was provided by the initial reporter: wed aug 30 14:18:48 utc 2023 - patient fields updated: hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details mismatch between 1 result in synapsys and what lis called out.Rootcause unclear yet.Sample nr (b)(6).In synapsys the result is (partially positive), in screen it the following result is stated: client already informed; destroy zas.[sic] this does not match.None of both.Their lis (screen it) was not able to receive partial results from synapsys, and the customer wanted to see if the issue was on bd side or on lis side.It was confirmed the issue is on lis side.No impact on patients.Wed (b)(6) 14:18:48 utc 2023 - patient fields updated: hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details mismatch between 1 result in synapsys and what lis called out.Rootcause unclear yet.(b)(6) : (b)(6) 2023 14:18:04 (gmt) sample nr (b)(6).In synapsys the result is (partially positive), in screen it the following result is stated: client already informed; destroy zas.[sic].This does not match.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17821301
• MDR Text Key: 324968625
• Report Number: 1119779-2023-01029
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 10/06/2023

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
• Device Operator: Other
• Device Catalogue Number: 444150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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