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

Model Number 342973

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

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

Event Date 11/05/2021

Event Type  malfunction  

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.Abnormal results".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is only limited to facscalibur cytometer 3 color basic ivd part # 342973, serial # (b)(6).Problem statement: customer reported a complaint regarding erroneous results.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 05nov2020 to date 05nov2021.Complaint trend: there are 2 complaints related to the issue of erroneous results.Date range from 05nov2020 to date 05nov2021.Manufacturing device history record (dhr) review: dhr part #342973 serial # (b)(6), file # 342973-342973-e34297300677-100520906-14, 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 could not be determined.The customer had initially reported that their instrument had been producing erroneous results.The tsr (technical service representative) sent the customer a quote for the repair since the instrument was out of warranty, and the customer rejected the repair.No repair was performed on this instrument at this time.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 #: n/a, case # (b)(4).Install date: 20jan2015.Defective part number: n/a.Case comments: out-of-warranty instrument, refused to pay for repair.Facscalibur-abnormal results.Clinical use.Clinical samples did not affect patient treatment.Returned sample evaluation: a return sample was not requested because there were no replaced parts.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.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 of the erroneous results could not be determined.Conclusion: based on the investigation results the root cause of the erroneous results could not be determined.The customer had initially reported that they observed abnormal results from their instrument, but also rejected the quote provided by the tsr on the cost of the repair.No repair was performed on this instrument at this time.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.H3 other text : see h.10.

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.Abnormal results".

• 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: 12863790
• MDR Text Key: 282583307
• Report Number: 2916837-2021-00464
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429738
• UDI-Public: 00382903429738
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 342973
• Device Catalogue Number: 342973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2014
• 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