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

Event Date 10/19/2020

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that erroneous results occurred while using a bd facscalibur flow cytometer, as indicated by "a large gap between same specimen samples." there was no report of patient impact.The following information was provided by the initial reporter: facscalibur's experimental results in the morning and the experimental results in the afternoon have a large gap, and there is a large gap between the same specimens and not used for patient treatment.Clinical use, apply for telephone guidance.Clinical use.Customer conducted a repeat/different test to confirm the results, the problem remains.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 facscalibur cytometer 3 color basic ivd part # 342973, serial # (b)(6).Problem statement: customer reported complaint of their experimental result being abnormal, possibly leading to erroneous results for ivd.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from (b)(6) 2019 to date (b)(6) 2020.Complaint trend: there are 3 complaints related to the issue of abnormal experimental results.Date range from (b)(6) 2019 to date (b)(6) 2020.Manufacturing device history record (dhr) review: dhr part # 342973 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 experimental results being abnormal could not be determined.No work order was created for an fse (field service engineer) visit as it seemed the instrument was running as expected.However, the customer was redirected to an application specialist for assistance that resolved the issue over the phone.The specialist can assist the customer in interpreting data, proper graph gating, adjusting settings to maximize performance and many more.No parts were requested for evaluation as not parts were replaced.Although the unexpected results were from experimental samples, 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.The safety risk is low as there was no impact to patient health or safety.Service max review: review of related work order #: n/a, case # (b)(4).Install date: (b)(6) 2015 defective part number: n/a.Work order notes: subject / reported: (b)(4)-facscalibur-experimental results have a big gap.Problem description: facscalibur's experimental results in the morning and the experimental results in the afternoon have a large gap, and there is a large gap between the same specimens and not used for patient treatment to clinical use, apply for telephone guidance.Work performed: n/a.Cause: n/a.Solution: n/a.Returned sample evaluation: a return sample was not requested because no parts were replaced.Risk analysis: risk management file part # (b)(4), rev.01/vers.A, bd facscalibur failure mode and effect analysis was reviewed.The severity rating in this file is ¿5¿ based on the previous scale rating.This rating is equivalent to ¿s2¿ in sop6078-02 rev.12/vers.J, 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.No new hazards have been identified and the current mitigations are sufficient hazard(s) identified? yes or no? item: facsflow supply system.Function: increase capacity of sheath and waste.Potential failure mode: time delay errors.Potential effects of failure: erroneous data.Potential causes/mechanisms of failure: sheath pump too strong.Current controls: facscomp.Recommended actions: n/a.Responsible party: n/a.Target completion date: n/a.Actions taken: n/a.Sev: 5.Occ: 3.Det: 5.Rpn: 75.Item: sheath filter 80-30038-07.Function: filter sheath.Potential failure mode: flow rate problems.Potential effects of failure: erroneous data.Potential causes/mechanisms of failure: bubbles in sheath filter.Current controls: facscomp co #(b)(4).Recommended actions: n/a.Responsible party: n/a.Target completion date: n/a.Actions taken: n/a.Sev: 5.Occ: 3.Det: 5.Rpn: 75.Mitigation(s) sufficient: yes or no? root cause: based on the investigation results the root cause could not be determined.Conclusion: based on the investigation results, the root cause of the customer obtaining abnormal results with the facscalibur could not be determined.An application specialist assisted the customer remotely to resolve any issues they were having.The instrument was performing as expected with no physical safety concerns.No one was harmed or injured, and no medical diagnosis was performed due to erroneous results.The safety risk is low as there was no impact to patient health or safety.

Event Description

It was reported that erroneous results occurred while using a bd facscalibur flow cytometer, as indicated by "a large gap between same specimen samples." there was no report of patient impact.The following information was provided by the initial reporter: facscalibur's experimental results in the morning and the experimental results in the afternoon have a large gap, and there is a large gap between the same specimens and not used for patient treatment.Clinical use, apply for telephone guidance.Clinical use.Customer conducted a repeat/different test to confirm the results, the problem remains.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 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
• MDR Report Key: 10795908
• MDR Text Key: 229957900
• Report Number: 2916837-2020-00230
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429738
• UDI-Public: 00382903429738
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• 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
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1