MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD SYNAPSYS¿ VIRTUAL SERVER; DATA MANAGEMENT SYSTEM

Catalog Number 444150

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

While reviewing healthcare records stored on a bd synapsys¿ virtual server laboratory information system (lis), it was determined a certain patient test had become mis-associated with a different test for that patient causing both tests to appear when one specimen number was queried.The patient was having what was believed to be two positive blood culture samples cultured on agar plates.The plates were inoculated on a bd kiestra¿ inoqula plate streaking instrument.The mis-associated plate was a duplicate of the other plate.The mis-associated plate was labelled in the lis as enterobacteriaceae.The other plate was initially labeled in the lis enterobacteriaceae and changed to ¿freeze¿.There was no indication that the patient was misdiagnosed based on erroneous medical information.

Manufacturer Narrative

Investigation summary: during investigation of the issue, a possible data association error in synapsys.This error manifested itself in two noticeable areas.Reading screen images of plate ¿ plates assigned to one specimen had a different accession stamp on the image (this stamp is put on the image by the imaging system in bdk).Culture search ¿ when searching for one specimen within synapsys by accession number, two specimens were returned.During investigation of the customer's database, the following was discovered: it was determined that 3 tests were associated to both specimens.The test hierarchy for these tests had them as children tests to a culture protocol order for specimen ¿a¿ while the specimen link for the tests themselves pointed to specimen ¿b¿.A query was written to find all instances of this mis-association, and it was found that there were 5 distinct instances where this mis-association had occurred.The log entries associated to these tests were reviewed to determine what features were in use at the time of the mis-association and the circumstances around error.The logs identified that the manual inoculation screen in synapsys was where the error occurred.A database change was made to identify the issue over data re-association and disallow it along with a user notification that the potential data re-association was not allowed.This change was made using scr 133223 and was released in the 2.2.2019.01601.The synapsys risk file was reviewed baltrm-synapsys-aph.A new mitigation was added as a result of this complaint (id 50) resulting in the 8f revision of this file.No other trends or new hazards were identified as a result of the complaint investigation.Sa bdds-19-1446-sa was created in response to this complaint investigation.Fa bdds-19-1446-fa has also been created in response to this complaint investigation.Upon investigation, the issue was confirmed as an issue in synapsys and documented in an internal problem tracking tool as scr 133223.This scr was addressed and the resolution was released in synapsys software version 2.2.2019.01601.Complaint confirmed.Root cause determined to be usage of the manual inoculation screen and culture scanning/selection and a combination of browser back/forward buttons.A capa was entered as a result of fa bdds-19-1446-fa indicating that an capa must be automatically generated.

Event Description

While reviewing healthcare records stored on a bd synapsys¿ virtual server laboratory information system (lis), it was determined a certain patient test had become mis-associated with a different test for that patient causing both tests to appear when one specimen number was queried.The patient was having what was believed to be two positive blood culture samples cultured on agar plates.The plates were inoculated on a bd kiestra¿ inoqula plate streaking instrument.The mis-associated plate was a duplicate of the other plate.The mis-associated plate was labelled in the lis as enterobacteriaceae.The other plate was initially labeled in the lis enterobacteriaceae and changed to ¿freeze¿.There was no indication that the patient was misdiagnosed based on erroneous medical information.

• Brand Name: BD SYNAPSYS¿ VIRTUAL SERVER
• Type of Device: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 8307332
• MDR Text Key: 135180185
• Report Number: 1119779-2019-00104
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

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
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other