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

Model Number	657338
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	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: (b)(6).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 facscanto¿ that there was erroneous results.The following information was provided by the initial reporter: patient sample.1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.Facscanto plus graph exception clinical, use of patient samples, no potential harm.
Additional Manufacturer Narrative
H6: investigation summary scope of issue: the scope of issue is only limited to facscanto ivd 10 color configuration, part # 657338 and serial # (b)(6).Problem statement: customer reported complaint regarding graph exception on (b)(6)2023.This poses the risk of producing delayed or 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) for part# 657338 related to the reported issue.Date range from 09mar2022 to 09mar2023.¿ device history record (dhr) review: dhr part # 657338 serial # (b)(6), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.¿ complaint history review: there are 3 complaints for part # 657338 related to the as reported code 1: result - erroneous diagnostic date range from 09mar2022 to 09mar2023.¿ returned sample analysis: a return sample was not requested for evaluation because no parts were replaced.¿ service history review: review of related work order #:(b)(4), case # (b)(4).Install date: 01aug2016 defective part number: n/a work order notes: work order notes: ¿ subject / reported: pi-657338 - facscanto plus - graphics anomaly ¿ problem description: facscanto plus - pattern abnormalities clinical, patient samples used, no potential harm o work performed: the optical path is calibrated, the quality control is passed, and the instrument is operating normally o cause: the signal is abnormal o solution: the optical path is calibrated, the quality control is passed, and the instrument is operating normally ¿ 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 # 500000301839 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 was an abnormal signal.¿ 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 graphics anomaly was an abnormal signal.The customer reported a complaint regarding a graphics anomaly.In an attempt to resolve the issue, the field service representative (fsr) calibrated the optical path.After the work performed, the instrument was tested and was performing 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.Proper daily and monthly cleaning and maintenance are vital for maintaining the instrument¿s health and performance level.This information can be found in the bd facscanto¿ flow cytometer instructions for use (ifu) manual, #23-14730-03 rev.1/vers.A.¿ conclusion: based on the investigation results, complaint was confirmed and the potential cause of the graphics anomaly was determined to an abnormal signal.In an attempt to resolve the issue, the fsr calibrated the optical path.After the work performed, the instrument was tested and was 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 while using the bd facscanto¿ that there was erroneous results.The following information was provided by the initial reporter: patient sample 1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.Facscanto plus - graph exception clinical, use of patient samples, no potential harm.

• Brand Name: BD FACSCANTO¿
• 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: 16607691
• Report Number: 2916837-2023-00077
• Device Sequence Number: 20047279
• Product Code: OYE
• UDI-Device Identifier: 00382906573384
• UDI-Public: 00382906573384
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: 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: 657338
• Device Catalogue Number: 657338
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2016
• 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