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

Catalog Number	338962
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd facscanto ii flow cytometer erroneous results were observed on patient samples.The following information was provided by the initial reporter: customer had irregularities with sample results.Customer states cst did however pass.
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
The following fields have been updated with corrected information: g.1 - reporting office contact - (b)(6).G.1 - manufacturing site contact -(b)(6).G.1 - reporting office-(b)(6).H6.Investigation summary: based on the investigation results, the reported issue of erroneous results was confirmed.Investigation results that were performed on the indicated failure mode were the following: based on the complaint trend, defect trend, dhr, risk analysis and service activity review, the complaint was confirmed, and the potential cause was determined to be the alignment.The fse performed alignment activities.The instrument was functioning as expected.No one was harmed or injured, and no patients were diagnosed or treated based on any erroneous results.The safety risk of this hazard has been identified to be within the acceptable level.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that while using bd facscanto?ii flow cytometer erroneous results were observed on patient samples.The following information was provided by the initial reporter: customer had irregularities with sample results.Customer states cst did however pass.

• Brand Name: BD FACSCANTO?II FLOW CYTOMETER
• 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: 17877180
• Report Number: 2916837-2023-00190
• Device Sequence Number: 20628803
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: 00382903389629
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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: 338962
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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