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

Catalog Number 444150

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported when discarding a plate from the workup screen with a bd synapsys¿ the organism data is sent and overwrites lis organism.

Manufacturer Narrative

H.6.Investigation: it was reported that when discarding a plate from the workup screen, organism data is sent over and overwrites lis organism.Logged in to find data on why the samples were being overwritten in netlims.It was found that when the customer uses a workflow of discarding plates from the workup screen, a final message is not sent to the lis.There is however, an organism message sent.Since this message has an organism which name has changed in the lis, it can cause the issue.Customer has changed workflow to prevent this from happening.The complaint is not confirmed.

Event Description

It was reported when discarding a plate from the workup screen with a bd synapsys¿ the organism data is sent and overwrites lis organism.

• Brand Name: BD SYNAPSYS
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11276042
• MDR Text Key: 231319941
• Report Number: 1119779-2021-00242
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

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: 01/12/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 06/08/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1