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

Catalog Number	338960
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	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that after using bd facscanto¿ ii flow cytometer erroneous results were acquired.The following information was provided by the initial reporter: issue with sample flow are there erroneous results on patient samples for diagnostic test? (if yes, go to question #2, if no, no further questions required.) yes 2.Was there any delay of treatment due to the issue? (go to question #3) no, client used back-up system.
Additional Manufacturer Narrative
H.6.Investigation summary: based on the investigation results, the reported issue for the issue with sample flow was confirmed.Investigation results that were performed on the indicated failure mode were the following : the potential cause of the issue with the sample flow was flow cell misalignment.The dhr was reviewed to confirm the instrument met all the manufacturing specifications prior to release.The field service representative (fsr) performed a field visit.The field service representative (fsr) performed a repair on the optical subsystem of the instrument.This includes adjusting the flow cell and aligning the laser.After the adjustments performed, the instrument was tested and confirmed to be performing according to the instrument specifications.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 after using bd facscanto¿ ii flow cytometer erroneous results were acquired.The following information was provided by the initial reporter: issue with sample flow.Are there erroneous results on patient samples for diagnostic test? (if yes, go to question #2, if no, no further questions required.) yes.2.Was there any delay of treatment due to the issue? (go to question #3) no, client used back-up system.

• 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: 18610708
• Report Number: 2916837-2024-00008
• Device Sequence Number: 16745613
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: (01)00382903389605
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K062087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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: 338960
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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