MAUDE Adverse Event Report: BECKMAN COULTER IRELAND NAVIOS EX FLOW CYTOMETER; FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.

Model Number	TN NAVIOS EX 10 COLORS/3 LASERS
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information was not provided by the customer.The field service engineer (fse) was onsite and found that two of the signal conditioner and amplifier (sca) boards were defective.To resolve the issue the fse replaced the cyto sca boards.The fse also discovered that the vent line from the instrument to the compressor cart appeared to have been slightly obstructed because of the way it was routed behind the instrument and down the front of the table.The fse re-routed the vent line to resolve the partial obstruction.The fse ran qc to verify proper operation of the unit.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported that erroneous/questionable were generated on the navios ex 10 colors/3 lasers flow cytometer when running a customer developed leukemia/lymphoid panel.Non-specific staining was observed which resulted in variability from tube to tube for the three-tube panel test.Erroneous results were not reported outside of the laboratory.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: NAVIOS EX FLOW CYTOMETER
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.
• Manufacturer (Section D): BECKMAN COULTER IRELAND; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 18422069
• Report Number: 1061932-2023-00110
• Device Sequence Number: 18185997
• Product Code: OYE
• UDI-Device Identifier: 15099590677466
• UDI-Public: (01)15099590677466(11)221010
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K162897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2023

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 EX 10 COLORS/3 LASERS
• Device Catalogue Number: B80910
• 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: 12/06/2023
• Initial Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown