MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO¿; COUNTER, DIFFERENTIAL CELL

Catalog Number	657338
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error messages were bypassed and testing was still able to continue during use with the bd facscanto¿.The following information was provided by the initial reporter: we have an error window popping up on our diva software after the end of certain panels but not all runs (leukemia panels, rituximab panels, etc.) also, our software seems to be running slow and has trouble accessing export folder files when doing the carousel setup.Steps taken with customer/troubleshooting: spoke with customer and they are having issues running some of their panels.Some panels work some do not.Suspect the panels are corrupt.Customer would like the fse to look at it additional information: 1.Are you running patient samples for diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes 2.Was there an error message? (if yes, go to question #3.If no, no further questions required.): yes.3.Did the customer bypass the error message? (if yes, go to question #4.If no, no further questions required.): yes.
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary: based on the investigation results, the reported issue of an error window popping up on diva software after the end of certain panels but not all runs was confirmed.Investigation results that were performed on the indicated failure mode were the following: the investigation was performed based on the review of complaint trend, risk analysis, and review of customer provided information.
Event or Problem Description
It was reported that error messages were bypassed and testing was still able to continue during use with the bd facscanto¿.The following information was provided by the initial reporter: we have an error window popping up on our diva software after the end of certain panels but not all runs (leukemia panels, rituximab panels, etc.) also, our software seems to be running slow and has trouble accessing export folder files when doing the carousel setup.Steps taken with customer/troubleshooting: spoke with customer and they are having issues running some of their panels.Some panels work some do not.Suspect the panels are corrupt.Customer would like the fse to look at it additional information: 1.Are you running patient samples for diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there an error message? (if yes, go to question #3.If no, no further questions required.): yes.3.Did the customer bypass the error message? (if yes, go to question #4.If no, no further questions required.): yes.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: d.4.Medical device serial #: (b)(6).D.4.Unique identifier (udi) #: (b)(4).H.6 imdrf annex b: b21.H.6 imdrf annex c: c21.H.6 imdrf annex d: d16.G.1.Reporting office: (b)(4).G.1.Reporting office contact: (b)(4) - mdr.G.1.Manufacturing site contact: (b)(4) - mdr.
Event or Problem Description
It was reported that error messages were bypassed and testing was still able to continue during use with the bd facscanto¿.The following information was provided by the initial reporter: we have an error window popping up on our diva software after the end of certain panels but not all runs (leukemia panels, rituximab panels, etc.) also, our software seems to be running slow and has trouble accessing export folder files when doing the carousel setup.Steps taken with customer/troubleshooting: spoke with customer and they are having issues running some of their panels.Some panels work some do not.Suspect the panels are corrupt.Customer would like the fse to look at it.Additional information: 1.Are you running patient samples for diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there an error message? (if yes, go to question #3.If no, no further questions required.): yes.3.Did the customer bypass the error message? (if yes, go to question #4.If no, no further questions required.): yes.

• Brand Name: BD FACSCANTO¿
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 17916628
• Report Number: 2916837-2023-00196
• Device Sequence Number: 6653205
• Product Code: OYE
• UDI-Device Identifier: 00382906573384
• UDI-Public: (01)00382906573384(11)151009(21)V657338000214
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2024

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 Catalogue Number: 657338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/15/2023; 08/30/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 08/27/2024; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown