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

Model Number	342975
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	01/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd facscalibur¿ flow cytometer that there were erroneous results.The following information was provided by the initial reporter: facscalibur - abnormal graphics, clinical use, results not used for patient diagnosis, out of warranty equipment, quote required.
Additional Manufacturer Narrative
Inital reporter phone # (b)(6).Pma / 510(k)#: k973483.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary.Scope of issue: the scope of issue is only limited to facscalibur cytometer 4 color basic ivd, part # 342975 and serial # (b)(6).Problem statement: customer reported a complaint regarding graph anomaly on (b)(6)2023.This poses the risk of producing erroneous results that might impact patient diagnosis and treatment.The instrument was repaired and found to be functioning as expected, and neither the customer nor any patients were harmed due to this issue.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 02jan2022 to 02jan2023.Device history record (dhr) review: dhr part # 342975, serial # (b)(6), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.Complaint history review: there are (b)(4) complaints related to the as reported code 1 ¿ result - unexpected; pr# (b)(4), 4391 date range from 02jan2022 to 02jan2023.Returned sample analysis: a return sample was not requested because no parts were replaced.Service history review: review of related work order #: (b)(4); case # (b)(4).Install date: 29oct2014.Defective part number: n/a.Work order notes: subject / reported: (b)(4) /facscalibur - pattern anomaly.Problem description: facscalibur - abnormal graphic, clinical use, results not used in patient diagnosis xuchang engineer feedback: paid.Work performed : the calibration signal, the quality control passed, the test sample was normal, and the instrument was running normally.Cause: the optical path needs to be calibrated.Solution: the calibration signal, the quality control passed, the test sample was normal, and the instrument was running normally.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 graph anomaly was a calibration/alignment issue of the optical path.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 graph anomaly was a calibration/alignment issue of the optical path.The customer reported a complaint regarding an abnormal graphic and a pattern anomaly.The field service representative (fsr) confirmed that the optical path was not calibrated.The fsr proceeded to adjust the signal.After the work performed, the issue was resolved.The instrument is confirmed to performing as intended.Although the unexpected 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 graph anomaly was a calibration/alignment issue of the optical path.The customer reported a complaint regarding an abnormal graphic and a pattern anomaly.The field service representative (fsr) confirmed that the optical path was not calibrated.The fsr proceeded to adjust the signal.After the work performed, the issue was resolved.The instrument is confirmed to 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.
Event or Problem Description
It was reported that while using the bd facscalibur¿ flow cytometer that there were erroneous results.The following information was provided by the initial reporter: facscalibur - abnormal graphics, clinical use, results not used for patient diagnosis, out of warranty equipment, quote required.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16215381
• Report Number: 2916837-2023-00009
• Device Sequence Number: 5416587
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/08/2023

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: 342975
• Device Catalogue Number: 342975
• 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: 01/02/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2014
• 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