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

Model Number	342973
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	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter e-mail: (b)(6).Initial reporter addr 1: (b)(6).Pma / 510(k)#: k923790, k973483.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 while using the bd facscalibur flow cytometer that there was erroneous result.The following information was provided by the initial reporter: showing wrong results.
Additional Manufacturer Narrative
H.6: scope of issue: the scope of issue is only limited to facscalibur cytometer 3 color basic ivd, part # 342973 and serial # (b)(6).Problem statement: customer reported a complaint regarding unexpected results on (b)(6) 2023.This poses the risk of producing erroneous results that might impact patient diagnosis and treatment.It was found that the customer was using calibration beads with old expiry date and could not reach the proper settings.After the works performed, the field service representative verified instrument performance by running calibrite 3-color beads and confirmed that it is performing as intended.Neither the customer nor any patients were harmed due to this issue.Manufacturing defect trend: there are zero qns (quality notifications) for part # 342973 related to the reported issue.Date range from 15mar2022 to 15mar2023.Device history record (dhr) review: dhr part # 342973, serial # (b)(6), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.Complaint history review: there are 2 complaints for part # 342973 related to the as reported code 1 ¿ result - unexpected; (b)(4) and this one, 7444215.Date range from 15mar2022 to 15mar2023.Returned sample analysis: a return sample was not requested for evaluation because there were no parts replaced.Service history review: review of related work order #: (b)(4); case # (b)(4) install date: (b)(6) 1990 defective part number: n/a work order notes: subject / reported: results issue problem description: showing wrong results work performed : attend the machine and cleaned fluidics and verified sheath, sample pressures were found normal.Cleaned optics and verified optical alignment by running nile red beads found all signals were optimized.Verified and adjusted the time delay calibration by running blue beads found it got passed successfully.Verified instrument performance by running calibrite 3-color beads found it got passed in lw wash and lnw.Instrument working normally cause: gating issue solution: as per service view instrument working satisfactory.For sample result analysis suggested to user need to contact application team.Case can be closed, parts replaced: n/a.Labeling / packaging review: n/a.Risk analysis: risk management file part # 342973ra, rev.04/vers.D, risk analysis facscalibur prod family was reviewed.This file did not contain the appropriate hazards and mitigations, and an eco has been opened to assess additional hazards and their risk levels.Ecr #(b)(4) has been created and will revise the existing calibur risk analysis document to include causes, mitigations, and risk ratings related to erroneous results.Potential causes: based on the investigation results, the potential cause of the unexpected result was a gating issue.Investigation result / analysis: the investigation was performed and based on the review of complaint trend, defect trend, dhr review, risk analysis, and service activity review, the potential cause of the unexpected result was a gating issue.The customer reported a complaint regarding incorrect results.The field service representative (fsr) performed a series of works during the visit.Firstly, they cleaned the fluidics and verified that the sheath and sample pressures were normal.They cleaned the optics and verified optical alignment by running nile red beads.Then, they verified and adjusted the time delay calibration by running blue beads.It was found that the customer was using calibration beads with old expiry date and could not reach the proper settings.Hence, they were getting incorrect results.After the works performed, the fsr verified instrument performance by running calibrite 3-color beads and confirmed that the instrument is performing as intended.Although the erroneous results were from patient samples, no patient was treated nor harmed from incorrect results.The results were captured prior to any diagnostic decision and was not reported to the clinician.Conclusion: based on the investigation results, the complaint was confirmed, and the potential cause of the unexpected results was a gating issue.The fsr performed a series of works including - cleaning optics, fluidics and adjusting the time delay calibration.They verified instrument performance and confirmed that the instrument is performing as intended.Based on the investigation results a capa is not required because the issue was resolved and there was no impact to customer and patient health or safety.Supporting document: n/a h3 other text : see h10.
Event or Problem Description
It was reported that while using the bd facscalibur flow cytometer that there was erroneous result.The following information was provided by the initial reporter: showing wrong results.

• 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
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16655373
• Report Number: 2916837-2023-00080
• Device Sequence Number: 15104910
• Product Code: GKZ
• UDI-Device Identifier: 00382903429738
• UDI-Public: 00382903429738
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K923790
• 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): 07/18/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• 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