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	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while testing patient samples on a bd facscanto¿ erroneous results were obtained.The % of cd19 are lower than expected, in the internal multicheck the % were correct.There was no patient impact.The following information was provided by the initial reporter, translated from italian to english: the% of cd19 in the analyzed samples are lower than expected.However, in the internal multicheck control the percentages are correct.Are there erroneous results on patient samples from diagnostic test? yes.Was there any delay of treatment due to the issue? no.If patient samples were redrawn, was there any change or delay of treatment? no.Was there any physical harm/injury to the patient due to the issue? no.
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary scope of issue: the scope of issue is only limited to facscanto ivd 10 color configuration, part #657338, serial # (b)(6).Problem statement: customer reported a complaint regarding their instrument producing erroneous results.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 08nov2020 to date 08nov2021.Complaint trend: there are 2 similar complaints related to the issue of erroneous results (b)(4) and this one (b)(4).Date range from 08nov2020 to date 08nov2021.Manufacturing 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.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 due to user errors in sample handling.The customer had initially reported that the cd19 percentages in the analyzed sample were lower than expected, though the multicheck control percentages were correct.During the remote consultation and the preventative maintenance of this instrument no issues could be found with the instrument¿s performance.Only the cd19 percentages were beyond expectations with the other values being within range.The tsr (technical service representative) in the call asked for scientific and sata support, and an as (application specialist) confirmed that the low percentages were not from an instrument problem, and rather an issue with the way the sample was handled.No parts were requested for evaluation as there were no replaced parts.Aside from the one instance of erroneous results, the instrument was working as expected.Although the instrument was being used for clinical diagnoses, the customer confirmed that they noticed the erroneous results immediately and they were not used in the treatment of any patients.They also confirmed that this incident did not delay the treatment of any patients.Instructions on how to properly run samples using the instrument can be found in the bd facscanto¿ flow cytometer instructions for use (ifu) manual, #23-14730-03 rev.1/vers.A.The safety risk of this hazard has been identified to be within the acceptable level.Service max review: review of related work order #: (b)(4), case # (b)(4).Install date: (b)(6) 2016.Defective part number: n/a.Work order notes: subject / reported: 657338 - facscanto ivd 10 color configuration - %cd19 basse.Problem description: the% of cd19 in the analyzed samples are lower than expected.However, in the internal multicheck control the percentages are correct.Work performed: 7 color setup passed successfully, cst not performed.Pm performed a few days ago by salvatore, there don't seem to be any technical problems.However, it is not certain that this is a problem with the sample marking kit (bd multitest ¿ imk kit, cat no.340503, lot 99022, expiry 31/05/22) as it says that the multicheck internal control shows the percentages waited.Only the samples seem to have lower% and only for cd19, the other markers are ok.Scientific and sata support notice.The customer cannot say if the problem started with the new lot, opening date (b)(6) 2021.For quality: the samples were patient samples but there was no impact and no harm on the patients, since the erroneus results have not been used.As giuseppina marchese confirms that the low% are due to the therapy administered.No technical instrumental problems.Cause: no technical problems, the low% are due to the therapy administered and not to reagent or instrument problems.Solution: the problem has been resolved and the instrument is operating according to bd specifications.Returned sample evaluation: a return sample was not requested because there were no replaced parts.Risk analysis: risk management file part #338960-03ra, rev.02/vers.A, bd facscanto ii flow cytometer (optics) fmea was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes no.Item: 9.4+2 filters.Function: 9.1 transmit and reflect correct optical wavelengths.Potential failure mode: 9.1.2 no signal in apc (4c multitest with trucount).Potential effects of failure: 9.1.2.3 no cd19 detected - wrong result.Potential causes/mechanisms of failure: 9.1.2.3.1 empty alexa700 filter slot.Current controls: none.Recommended actions: 1.Design for fixed (nonuser-adjustable) filter configuration (4+2 filter set = 5+3 filter set).2.Instructions for use to instruct users not to alter filter configuration.Responsible party: 1.R&d.2.Tech pubs.Target completion date: (b)(6) 2006.Actions taken: 1.Done.See bd facscanto ii ifu (640773) - chapter 1 for description and drawings of filter configurations2.Bd facscanto ii ifu (640773)- chapter 5.Sev: 8.Occ: 1.Det: 7.Rpn: 56.Mitigation(s) sufficient yes no.Root cause: based on the investigation results the root cause of the erroneous results was due to user errors in sample handling.Conclusion: based on the investigation results the root cause of the erroneous results was due to user errors in sample handling.The customer confirmed that the tests run on the instrument passed without issue.After receiving help from an as, it was determined that the erroneous results were due to user errors.Aside from the one instance of erroneous results found in this incident, the instrument seemed to have no technical problems and was functioning as expected.No treatment or diagnosis was given using the unexpected results.The safety risk of this hazard has been identified to be within the acceptable level.
Event or Problem Description
It was reported that while testing patient samples on a bd facscanto¿ erroneous results were obtained.The % of cd19 are lower than expected, in the internal multicheck the % were correct.There was no patient impact.The following information was provided by the initial reporter, translated from italian to english: the% of cd19 in the analyzed samples are lower than expected.However, in the internal multicheck control the percentages are correct.Are there erroneous results on patient samples from diagnostic test? yes.Was there any delay of treatment due to the issue? no.If patient samples were redrawn, was there any change or delay of treatment? no.Was there any physical harm/injury to the patient due to the issue? no.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12936545
• Report Number: 2916837-2021-00478
• Device Sequence Number: 4830516
• Product Code: OYE
• UDI-Device Identifier: 00382906573384
• UDI-Public: 00382906573384
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/08/2022

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: 11/08/2021
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• 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