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

Catalog Number 444150

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/19/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Initial reporter facility name: (b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd synapsys¿ there was a bottle that turned positive and was removed from the instrument for culture.After being cultured the result was manually set by the user to unspecified since the bottle turned out to be a false positive.The bottle was not returned to the instrument but three days later the result updated to positive in synapsis, which triggered the positive result to upload to the lis again and caused the lis report to be unverified.No patient impact reported.The following information was provided by the initial reporter: an instrument positive blood culture test result was removed from the instrument for culture.After culture the blood culture result was manually set by the user to 'unspecified' since the bottle was a false positive.The bottle was not returned to the instrument.Three days later the result was updated to 'positive' in synapsys by the instrument (stack 2).This triggered the positive result upload to the lis again and caused the lis report to be unverified.Example sequence numbers: (b)(4).

Event Description

It was reported that while using bd synapsys¿ there was a bottle that turned positive and was removed from the instrument for culture.After being cultured the result was manually set by the user to unspecified since the bottle turned out to be a false positive.The bottle was not returned to the instrument but three days later the result updated to positive in synapsis, which triggered the positive result to upload to the lis again and caused the lis report to be unverified.No patient impact reported.The following information was provided by the initial reporter: an instrument positive blood culture test result was removed from the instrument for culture.After culture the blood culture result was manually set by the user to 'unspecified' since the bottle was a false positive.The bottle was not returned to the instrument.Three days later the result was updated to 'positive' in synapsys by the instrument (stack 2).This triggered the positive result upload to the lis again and caused the lis report to be unverified.Example sequence numbers: 446573080110 and 449284498072.

Manufacturer Narrative

H.6 investigation summary: this statement is to summarize the investigation of a complaint involving synapsys product number 444150, serial number (b)(6).According to information provided, the instrument erroneously updated a blood culture test result from 'unspecified' to 'positive'.No other issues were reported.Investigation by bd service personnel found that a 'positive' blood culture test had been removed from the instrument for culture.After culture, the result was manually changed by the user to 'unspecified', having been assessed as a 'false positive' result.Three days later, the instrument updated the result to 'positive' in synapsys, even though the bottle had not been returned to the instrument.This in turn triggered the 'positive' result to upload to the lis again, causing the lis report to be unverified.As 'unspecified' is not a valid manual option when a bottle results 'positive', it is unclear how the user was reportedly able to perform this action.The instrument did, however, function properly in this case when it re-updated the result from 'unspecified' to 'positive'.Efforts by service personnel to replicate the situation were unsuccessful and the root cause could not be determined.Based on this evaluation, this case has been assessed as unconfirmed with no synapsys quality issue or malfunction identified.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.Bd will continue to monitor reports of this type.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 ; 8015296192
• MDR Report Key: 15450725
• MDR Text Key: 300578218
• Report Number: 1119779-2022-01205
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• 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: 01/26/2023

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: 08/22/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• 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