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 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

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 bd facscalibur¿ flow cytometer acquired erroneous results on patient samples.The following information was provided by the initial reporter: " are there erroneous results on patient samples for 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.Facscalibur-poor experimental results, clinical use, no diagnosis report, no impact on patient treatment.".

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is only limited to facscalibur cytometer 4 color basic ivd, part#: 342975, serial#: (b)(6).Problem statement: customer reported complaint on the instrument producing erroneous results.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 10nov2020 to date 10nov2021.Complaint trend: there are 8 complaints related to the issue of erroneous results.Date range from 10nov2020 to date 10nov2021.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 a dirty flowcell.The customer had initially reported that their instrument was producing erroneous results.The instrument was being used for clinical diagnoses, but there was no impact on any patient¿s treatment.The fse (field service engineer) confirmed the issue, cleaned the flowcell, and calibrated the optical path.After the repair, the instrument was tested and functioning as expected.No parts were requested for evaluation as there were no parts replaced.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.Proper daily and monthly cleaning and maintenance can help mitigate instrument failures, and instructions can be found in the ¿maintenance¿ section of the bd facscalibur system user¿s guide, #: 338455 rev.A/vers.01.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: on (b)(6) 2007.Defective part number: n/a.Work order notes: subject / reported: pi-342975-facscalibur-poor experimental results.Problem description: facscalibur-poor experimental results, clinical use, no diagnostic report, no impact on patient treatment (b)(6).Work performed: clean the flow chamber, calibrate the light path, and the instrument is normal.Cause: clean the flow chamber, calibrate the light path, and the instrument is normal.Solution: clean the flow chamber, calibrate the light path, and the instrument is normal.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: 3.1.4 operational hazard ¿ fl3 separation qc failure.Hazard: fl3 filter¿s optical characteristic is not optimal.Cause: cannot proceed with clinical results after qc failure.Harmful effects: new fl3 filter to optimize optical characteristics.Implementation verification: verification protocol and report vp12256.Effectiveness verification: 500000189287.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 of the erroneous results was due to a dirty flowcell.Conclusion: based on the investigation results the root cause of the erroneous results was due to a dirty flowcell.The fse confirmed the issue, cleaned the flow chamber, and calibrated the optical path.After the repair, the instrument was 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 of this hazard has been identified to be within the acceptable level.

Event Description

It was reported that bd facscalibur¿ flow cytometer acquired erroneous results on patient samples.The following information was provided by the initial reporter: "1.Are there erroneous results on patient samples for diagnostic test? yes.2.Was there any delay of treatment due to the issue? no.3.If patient samples were redrawn, was there any change or delay of treatment? no.4.Was there any physical harm/injury to the patient due to the issue? no.Facscalibur-poor experimental results, clinical use, no diagnosis report, no impact on patient treatment.".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12936541
• MDR Text Key: 282291654
• Report Number: 2916837-2021-00479
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K973483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• 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: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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