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

Catalog Number 338960

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

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 06/13/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.(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 a positive patient sample was re-ran and result was negative with a bd facscanto ii cytometer.The following information was provided by the initial reporter, translated from (b)(6) to english: originally it is a positive specimen ,the result is negative clinical, patient specimens, hope to come home early on monday morning 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 obtained or used.No delay or altercation of treatment due to this problem.

Manufacturer Narrative

H.6.Investigation: problem statement: customer reported complaint on a bd facscanto ii cytometer 4/2 system ivd ¿ 338960 that the signal is weak affecting b27 which a confirmed positive specimen showed negative results.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 13jun2019 to date 13jun2020.Complaint trend: there are two complaints, related to this issue of a weak signal affecting b27.Date range from 13jun2019 to date 13jun2020.Manufacturing device history record (dhr) review: review of 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, and risk analysis, the root cause of the weak signal affecting b27 was due to a faulty blue laser fiber.The fse (field service engineer) confirmed this issue after troubleshooting and checking the signals on the instrument.He replaced the faulty part, #335384 - kineflex blue laser fiber, and the instrument was running normally after the repair.This part was requested for a sample evaluation but was discarded by the fse after replacing the part.The customer noticed the discrepancy of the positive sample showing negative results, therefore conducted a repeat test with a different sample to confirm the results.The issue still remained so a work order was eventually opened to have the instrument looked at.Although this instrument is for clinical use and initially involved a patient sample for testing, no clinical tests were continued and no results were used in patient diagnosis or treatment.There was no harm or injury.After the repair, the instrument was rebooted, tested and functioning as expected.The safety risk is low because there was no impact to patient health or safety service max review: review of related work order #: (b)(4), case #: (b)(4).Install date: 01sep2017.Defective part number: 335384 - kineflex blue laser fiber.Work order notes: subject / reported: 338960-facscanto ii-weak signal.Problem description: facscanto ii-the signal is weak, affecting b27.It was originally a positive specimen, but it was negative.Clinical, patient specimens, hope to come early on monday morning.Work performed: check the signal of the instrument, the blue laser fiber is faulty, replace the blue laser fiber, and calibrate the signal.Cause: blue fiber failure.Solution: check the signal of the instrument, the blue laser fiber is faulty, replace the blue laser fiber, and calibrate the signal.Returned sample evaluation: a return sample was requested but it was discarded by the fse.Risk analysis: risk management file part #338960-03ra, revision 02/version a, bd facscanto ii flow cytometer (optics) fmea was reviewed.No new hazard have been identified and the current mitigations are sufficient.Hazard(s) identified? yes; no.Item: 3.Blue laser; function: 2.1 excites blue dyes; potential failure mode: 2.1.1 low power; potential effects of failure: 2.1.1.1 detection sensitivity specifications not met.Potential causes/mechanisms of failure: 2.1.1.1.1 power dropping; current controls: feedback system; recommended actions: n/a; responsible party: n/a; target completion date: n/a; actions taken: n/a; sev: 4; occ: 2; det: 3; rpn: 24.Mitigation(s) sufficient yes no.Root cause: based on the investigation results the root cause was due to a faulty 335384 - c.Conclusion: based on the investigation results, the root cause of the weak signal affecting b27 was due to a faulty kineflex blue laser fiber, part# 335384.The fse had confirmed the issue and performed the repair.The instrument was rebooted, tested and functioning as expected.The safety risk is low because there was no impact to patient health or safety.H3 other text : see h.10.

Event Description

It was reported that a positive patient sample was re-ran and result was negative with a bd facscanto ii cytometer.The following information was provided by the initial reporter, translated from chinese to english: originally it is a positive specimen, the result is negative clinical, patient specimens, hope to come home early on monday morning 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 obtained or used.No delay or altercation of treatment due to this problem.

• Brand Name: BD FACSCANTO II 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: 10236346
• MDR Text Key: 202708136
• Report Number: 2916837-2020-00037
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 0382903389605
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other