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

Model Number 338960

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.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.(b)(4).

Event Description

It was reported that during use with bd facscanto¿ ii flow cytometer there were erroneous cytokine results on patient sample.The test was repeated and issue remained.Results were not reported, and there was no patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: 1facscanto ii cytokine test result is not good, sample test, not used for patient treatment 2 clinical use.Customer conducted a repeat/different test to confirm the results, the problem remains.The patient sample was used during this test.There was no impact to patient samples and no physical harm/injury due to the issue.No incorrect results been used.No delay or altercation of treatment due to this problem.

Manufacturer Narrative

H.6.Investigation: 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 complaint on the instrument producing erroneous results.Manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from 26oct2019 to date 26oct2020.Complaint trend: the only complaint related to the issue of erroneous results is this one.Date range from 26oct2019 to date 26oct2020.Manufacturing device history record (dhr) review: dhr part #338960 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 misaligned optics.As the exact cause for the misalignment could not be determined, several risks related to misalignment have been listed in risk analysis section below.Possible causes to the misalignment include movement during shipping, misalignment during preventative maintenance, and an out of focus collection lens.The fse (field service engineer) checked the issue onsite and checked the performance of the instrument.They then adjusted the optical path and confirmed that the instrument was working as intended.No parts were requested for evaluation as no parts were in need of repair or had to be replaced.Although the unexpected results were from patient samples, the customer confirmed that no patient was treated nor harmed from incorrect results.The results were captured prior to any diagnosis decision and was reported to bd as not expected.After the repair, the instrument was rebooted, tested and functioning as expected.The safety risk is limited, s2, and there was no impact to patient health or safety.Service max review: review of related work order #: 01658394, case # (b)(4).Install date: (b)(6) 2020.Defective part number: n/a.Work order notes: subject / reported: pi-338960-facscanto ii- cytokine test results are not good.Problem description: 1facscanto ii cytokine test results are not good, sample test, not used for patient treatment.2 clinical use work performed: check the machine, adjust the light path, and return to normal use of the instrument.Cause: check the machine, adjust the light path, and return to normal use of the instrument.Solution: check the machine, adjust the light path, and return to normal use of the instrument.Returned sample evaluation: a return sample was not requested because there were no parts that were damaged or needed to be replaced.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 mitigation is sufficient.Potential failures related to the issue of misaligned optics have been listed below.The severity rating in this file is ¿5¿ based on the previous scale rating.This rating is equivalent to ¿s2¿ in sop6078-02 whereby the unexpected result is obvious or indicated by additional (warning) information and hence the impact to the patient is negligible to none.The current mitigations are adequate with rpn under acceptable range.Hazard(s) identified? yes no.Item: 2.Filters.Function: 2.1 pass correct light wavelength bands.Potential failure mode: 2.1.1 not positioned properly in holder.Potential effect(s) of failure: 2.1.1.1 events not detected or misclassified.Potential cause(s)/mechanism(s) of failure: 2.1.1.1.1 loose filters, might fall out during shipping.Current controls: foam holds filters in during shipping.Severity: 5.Occurrence: 4.Detection: 3.Rpn: 60.Item: 7.Collection lens.Function: 7.1 focus broadband light onto collection fibers.Potential failure mode: 7.1.1 light is not adequately focused.Potential effect(s) of failure: 7.1.1.1 poor sensitivity, misclassification.Potential cause(s)/mechanism(s) of failure: 7.1.1.1.1 less than ideal chromaticity in collection lens ¿ compromise wavelength must be chosen to optimize alignment.Current controls: once lens is set during manufacturing, installation and/or during pms, the lens performance does not change.Severity: 8.Occurrence: 1.Detection: 1.Rpn: 8.Item: 12.Fluorescence detection channel.Function: 12.1 resolve particles in fluorescence.Potential failure mode: 12.1.1 cv goes out of specification over time (between pms).Potential effect(s) of failure: 12.1.1.1 clinical applications unable to id populations, misdiagnosis.Potential cause(s)/mechanism(s) of failure: 12.1.1.1.1 drift in alignment.Current controls.1.Intrinsically broad cvs of populations in clinical samples 2.Process controls for 4c multitest, 6c multitest, future applications (stem cell enumeration kit, tritest, leucocount).3.Algorithm flags: bead gate, cd3 separation, default-gating-used flag (for quadrants).Severity: 8.Occurrence: 1.Detection: 5.Rpn: 40.Mitigation(s) sufficient yes no.Root cause: based on the investigation results the root cause was due to a misaligned optics.Conclusion: based on the investigation results, the root cause of the instrument producing erroneous results was due to misaligned optics.The fse confirmed the issue onsite and adjusted the optical paths of the instrument.After the repair, the instrument was rebooted, tested, and functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the erroneous results.The safety risk is limited, s2, and there was no impact to patient health or safety.

Event Description

It was reported that during use with bd facscanto¿ ii flow cytometer there were erroneous cytokine results on patient sample.The test was repeated and issue remained.Results were not reported, and there was no patient impact.The following information was provided by the initial reporter, translated from chinese to english: 1facscanto ii cytokine test result is not good, sample test, not used for patient treatment.2 clinical use.Customer conducted a repeat/different test to confirm the results, the problem remains.The patient sample was used during this test.There was no impact to patient samples and no physical harm/injury due to the issue.No incorrect results been used.No delay or altercation of treatment due to this problem.

• Brand Name: BD FACSCANTO II FLOW CYTOMETER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10843820
• MDR Text Key: 232003346
• Report Number: 2916837-2020-00249
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• PMA/PMN Number: K062087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 338960
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1