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

Model Number	TN,NAVIOS 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	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) confirmed what the customer had reported.To resolve the issue the fse adjusted the low flow rate and realigned the lasers.Bec internal identifier (b)(4).
Event or Problem Description
The customer reported getting frequent blue laser warnings and unexpected mean variability on patient samples that were run on the navios flow cytometer.Questioned results were generated but not reported out of the lab.Patient samples were rerun on another instrument and those results were considered correct.There was no reported death, injury or change to patient treatment.

• Brand Name: NAVIOS FLOW CYTOMETER SYSTEM
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.
• Manufacturer (Section D): BECKMAN COULTER IRELAND; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• MDR Report Key: 11611446
• Report Number: 1061932-2021-00048
• Device Sequence Number: 19749615
• Product Code: OYE
• UDI-Device Identifier: 15099590515522
• UDI-Public: (01)15099590515522(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1