MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Model Number 342973

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

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 that during use with a bd facscalibur flow cytometer there was an error message during run with patient samples, however, the samples were able to be fully processed.There was no reported patient impact.The following information was provided by the initial reporter: communication was made with the user and suggestions were made to launch the program again.The ërror program¨ message appeared at the end of running the samples, but the sample was processed.¿ additionally, on 2020-9/15 2020 the fse provided the following additional information: was there any impact to the patient(s)? no.Were samples redrawn? no.Was there any delay in treatment? no.The run was with patient samples.The equipment is used for clinical tests.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2020-00163 was sent in error.Error message produced no results on patient samples, therefore this is not considered to be a reportable malfunction.

Event Description

It was reported that during use with a bd facscalibur flow cytometer there was an error message during run with patient samples, however, the samples were able to be fully processed.There was no reported patient impact.The following information was provided by the initial reporter: communication was made with the user and suggestions were made to launch the program again.The ërror program¨ message appeared at the end of running the samples, but the sample was processed.¿ additionally, on (b)(6) 2020 the fse provided the following additional information: was there any impact to the patient(s)? no.Were samples redrawn? no.Was there any delay in treatment? no.The run was with patient samples.The equipment is used for clinical tests.

• Brand Name: BD FACSCALIBUR FLOW CYTOMETER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10639522
• MDR Text Key: 212084647
• Report Number: 2916837-2020-00163
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429738
• UDI-Public: 00382903429738
• Combination Product (y/n): N
• PMA/PMN Number: K973483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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 Model Number: 342973
• Device Catalogue Number: 342973
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other