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	06/01/2022
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 during testing of patient samples with bd facscanto¿ erroneous results were obtained.There was no patient impact.The following information was provided by the initial reporter, translated from chinese to english: the test result of the instrument was not accurate.The engineer in the hospital adjusted the instrument, the instrument runs normally.Using patient samples, inaccurate results were obtained but not used, did not affect patient treatment.
Event or Problem Description
It was reported that during testing of patient samples with bd facscanto¿ erroneous results were obtained.There was no patient impact.The following information was provided by the initial reporter, translated from chinese to english: the test result of the instrument was not accurate.The engineer in the hospital adjusted the instrument, the instrument runs normally.Using patient samples, inaccurate results were obtained but not used, did not affect patient treatment.
Additional Manufacturer Narrative
H6: investigation summary 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 erroneous results.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 17aug2021 to 17aug2022.Complaint trend: there are 3 complaints related to the issue of erroneous results and this one.Date range from 17aug2021 to 17aug2022.Manufacturing device history record (dhr) review: dhr part # 657338, serial # (b)(6), file # 657338-657338-v657338000610-106650281-20, was reviewed.The instrument met all the manufacturing specifications prior to release.Investigation result/analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis, and servicemax the root cause of the erroneous results was alignment or adjustment issues.The customer reported a complaint regarding erroneous results.The test result of the instrument was not accurate.This was resolved by the hospital engineer by adjusting the instrument.It is confirmed that the instrument is performing as intended.No parts were requested for evaluation because no parts were replaced.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.Service max review: review of related work order #: na, case # na.Install date: (b)(6) 2020.Defective part number: na.Work order notes: na.Returned sample evaluation: a return sample was not requested because there were no replaced parts.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.Root cause: based on the investigation results the root cause of the erroneous results was alignment or adjustment issues.Conclusion: based on the investigation results, the root cause of the erroneous results was alignment or adjustment issues.The test result of the instrument was not accurate.This was resolved by the hospital engineer by adjusting the instrument.It is confirmed that the instrument is performing as intended.Supporting document: n/a.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15321196
• Report Number: 2916837-2022-00234
• Device Sequence Number: 5888828
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 08/17/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• 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