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

Model Number	342973
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10639522
• Report Number: 2916837-2020-00163
• Device Sequence Number: 3094050
• Product Code: GKZ
• UDI-Device Identifier: 00382903429738
• UDI-Public: 00382903429738
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K973483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Model Number: 342973
• Device Catalogue Number: 342973
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other