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

Model Number 342975

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2021

Event Type  malfunction  

Event Description

It was reported that while testing patient samples with bd facscalibur¿ flow cytometer erroneous results were obtained.The results were not reported and there was no patient impact.The following information was provided by the initial reporter: are there erroneous results on patient samples for diagnostic test? (if yes, go to question #2, if no, no further questions required.) yes.Was there any delay of treatment due to the issue? (go to question #3) no.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4) not applicable.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.Provide details - how and to what extent? (go to question #6) what is the current medical status? (no further questions required.).

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.

Event Description

It was reported that while testing patient samples with bd facscalibur¿ flow cytometer erroneous results were obtained.The results were not reported and there was no patient impact.The following information was provided by the initial reporter: abnormal results: 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) not applicable.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.5.Provide details - how and to what extent? (go to question #6).6.What is the current medical status? (no further questions required).

Manufacturer Narrative

H6: investigation summary: scope of issue: the scope of issue is only limited to facs calibur cytometer 4 color basic ivd, part # 342975, serial # (b)(6).Problem statement: customer reported a complaint regarding the instrument producing erroneous results.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 25nov2020 to date 25nov2021.Complaint trend: there are 8 complaints related to the issue of erroneous results; date range from (b)(6) 2020 to date (b)(6) 2021.Manufacturing device history record (dhr) review: dhr part #342975 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 calibration issues.The customer had reported that they discovered the erroneous results when trying to run samples with failing fsc, ssc, and fl3.Long cleans and calibration has been performed prior to the field service as there were no cd4 reagents onsite.An fse (field service engineer) was deployed onsite when the reagents were available and checked the resolution and cvs for all parameters using the nilered beads.The instrument¿s resolution and cvs were okay, so the fse concluded that the issue was with calibration prior to erroneous results.No parts were requested for evaluation as there were no replaced parts.Although the unexpected results were from patient samples who may be affected by an incorrect analysis of their samples, no patient was treated nor harmed from incorrect results.The results were captured prior to any diagnostic decision and these results were easily identified as erroneous.The safety risk is moderate, s3, and there was no impact to patient health or safety.Service max review: review of related work order #: (b)(4), case # (b)(4).Install date: 12may2015.Defective part number: n/a.Work order notes: subject / reported: abnormal cd4 results.Problem description: instrument giving higher than normal values for cd4 sample results, as reported by customer.Work performed: checked latest facscomp report - fsc, ssc, fl3 failed.Checked resolution and cvs for all parameters using nilered beads - resolution and cvs okay.Cause: calibration issue.Solution: n/a.Returned sample evaluation: a return sample was not requested because there was no replaced part.Risk analysis: risk management file part # 342973ra, rev.04/vers.D, bd facscalibur product family risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes / no.Id: 3.1.5 operational hazard ¿ fl3 separation qc failure.Hazard: instrument parameters not optimized.Cause: cannot proceed with clinical results after qc failure.Harmful effects: poor separation and gates do not work as desired leading to wrong result.Risk control: optimize instrument.Implementation verification: service bulletin: fcb-19-11 (fl3 sensitivity separation failure).Effectiveness verification: 1.Implementation of service bulletin via servicemax.2.Product tech support engineer performed effectively check via servicemax qo audit.Probability: 1.Severity: 3.Risk index: 3.Residual risk evaluation: a.New hazards: none.Mitigation(s) sufficient: yes / no.Root cause: based on the investigation results the root cause was due to suboptimal instrument parameters.Conclusion: root cause: based on the investigation results the root cause was due to suboptimal instrument parameters.The fse confirmed the issue and found that the latest facscomp report had resulted in the fsc, ssc, and fl3 failing.Additionally, prior to the field service the customer calibrated the instrument and performed a long clean.The fse then checked the resolution and cvs for all the parameters using the new nilered beads and they were all okay.After the fse visit, the instrument was functioning as expected and it was concluded that the issue was with calibration prior to the last instance of erroneous results.No one was harmed or injured, and no medical diagnosis was performed due to the erroneous results.The safety risk is moderate, s3, and there was no impact to patient health or safety.

• Brand Name: BD FACSCALIBUR¿ FLOW CYTOMETER
• Type of Device: 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: 13053984
• MDR Text Key: 289972588
• Report Number: 2916837-2021-00495
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: K923790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 342975
• Device Catalogue Number: 342975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1