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

Model 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	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd facscanto¿ ii flow cytometer acquired erroneous results on patient samples.The following information was provided by the initial reporter: 1.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 3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4) no 4.Was there any physical harm/injury to the patient due to the issue? (if yes, go to question #5.If no, no further questions required) no customer reported unsatisfactory sample loading results.
Additional Manufacturer Narrative
H6: investigation summary ¿ scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4/2 system ivd, part # 338960 and serial # (b)(6).¿ problem statement: customer reported a complaint regarding unsatisfactory results on (b)(6) 2023.This poses the risk of producing delayed or erroneous results that might impact patient diagnosis and treatment.The issue was resolved and the instrument was 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 for part # 338960.Date range from (b)(6) 2022 to (b)(6) 2023.¿ manufacturing device history record (dhr) review: dhr part # 338960 serial # (b)(6), file # (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.¿ complaint trend: there are 28 complaints related to as reported code 1- result - unexpected for part # 338960; date range from (b)(6) 2022 to (b)(6) 2023.¿ returned sample analysis: a return sample was not requested for evaluation because there were no replaced parts.¿ service history review: review of related work order #: (b)(4); case # (b)(4) install date: (b)(6) 2014 defective part number: n/a work order notes: o subject / reported: pi-338960/facscanto ii - unsatisfactory sample loading results o problem description: facscanto ii - sample loading results are not satisfactory, clinical use, no results, no impact on patient treatment, overinsurance equipment, application for telephone support o work performed: call to understand the condition of the instrument to guide the customer to run the cst program, cst by guiding the customer to adjust the sample signal voltage, the problem is solved, the experiment is normal o cause: the customer reported that the instrument loading signal was abnormal and the experimental data was abnormal o solution: call to understand the condition of the instrument to guide the customer to run the cst program, cst by guiding the customer to adjust the sample signal voltage, the problem is solved, the experiment is normal.¿ labeling / packaging review: n/a ¿ risk analysis: risk management file part # 338942ra, revision 09/version h, facscanto product family risk analysis was reviewed.This file did not contain the appropriate hazards and mitigations, and an ecr has been created to assess additional hazards and their risk levels.Ecr # (b)(4) has been created and will revise the existing document to include causes, mitigations, and risk ratings for failures related to erroneous results.¿ potential causes: based on the investigation results, the potential cause of the erroneous results was an abnormal instrument loading signal.¿ investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis, and servicemax, the potential cause of the erroneous results was an abnormal instrument loading signal.The customer reported a complaint regarding unsatisfactory sample loading results.The field service representative (fsr) guided the customer to run the cst program.The customer reported that the instrument loading signal was abnormal and the experimental data was abnormal.After guiding the customer to adjust the sample signal voltage, the issue was resolved.The instrument is confirmed to be functioning as intended.Although the instrument was used for diagnostic testing the issue was identified and resolved before the patient sample results were used for any diagnosis or treatment.Troubleshooting procedures can be found in the ifu, bd facscanto¿ ii flow cytometer instructions for use (ifu) manual, #23-20269-00 rev.1/vers.A.¿ conclusion: based on the investigation results, the complaint was confirmed and the potential cause of the erroneous results was an abnormal instrument loading signal.The customer reported a complaint regarding unsatisfactory sample loading results.The fsr guided the customer to adjust the sample signal voltage and run the cst program, after which the issue was resolved.The instrument is confirmed to be 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.
Event or Problem Description
It was reported that bd facscanto¿ ii flow cytometer acquired erroneous results on patient samples.The following information was provided by the initial reporter: 1.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 3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4) no 4.Was there any physical harm/injury to the patient due to the issue? (if yes, go to question #5.If no, no further questions required) no customer reported unsatisfactory sample loading results.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16503717
• Report Number: 2916837-2023-00065
• Device Sequence Number: 14984821
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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: 338960
• 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: 03/05/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2013
• 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