MAUDE Adverse Event Report: BECKMAN COULTER, INC. NAVIOS FLOW CYTOMETER; FLOW CYTOMETRY ANALYSER IVD, SEMI-AUTOMATED

Model Number	TN NAVIOS 10 COLORS/3 LASERS
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported observing unexpected scatter patterns for cd45+ versus forward scatter (fs) and cd45 versus side scatter (ss), when running their laboratory developed test (ldt) protocol on the navios 10 color/3 laser flow cytometer.The issue was observed on cd45 which could potentially impact any of the cd markers run on any test panel.The test runs were rejected as invalid and run on a second instrument with no issue.There was no report of an injury, death, or impact on treatment or diagnosis related to the reported issue.There were no reports of harm to a patient, an operator.The user followed the published instructions and did not report the suspicious results.
Additional Manufacturer Narrative
The beckman field service engineer (fse) performed routine troubleshooting and found that when running flow check the peak at fl10 was broad and could not be improved.The fse resolved the issue by replacing the violet laser.Per navios instructions for use (pn: a96247): there is a risk of reporting incorrect results.Data displays used to arrive at the test result for light scatter patterns, antibody staining profiles, and all gates and boundaries should be reviewed by a laboratory professional when interpreting the data.If results are suspect, follow your laboratory's procedures to resolve.Bec internal identifier - (b)(4).

• Brand Name: NAVIOS FLOW CYTOMETER
• Common Device Name: FLOW CYTOMETRY ANALYSER IVD, SEMI-AUTOMATED
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 11800 sw 147th ave.; miami FL 33196
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 23343880
• Report Number: 1061932-2025-00033
• Device Sequence Number: 9544275
• Product Code: OYE
• UDI-Device Identifier: 15099590515522
• UDI-Public: (01)15099590515522(11)151214
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K183592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TN NAVIOS 10 COLORS/3 LASERS
• Device Catalogue Number: A52103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/20/2025
• Date Device Manufactured: 12/14/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown