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	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided by the customer.The field applications specialist (fas) assisted the customer in running the auto setup protocol to create new compensation settings as per normal work flow in the instructions for use.The fas found there were no compensation settings in the tetra protocol.The field applications specialist (fas) assisted the customer in running the auto setup protocol to create new compensation settings.There was no malfunction of the instrument identified.Bec internal identifier: (b)(4).
Event or Problem Description
The customer reported tetracxp patient panel results all positioned in quadrant 2 on their navios flow cytometer.Erroneous patient results may have been generated but were discarded due to control failure.There was no reported death, injury or change to patient treatment.The customer runs the auto setup once a week and uses the same settings to run sample controls and patient samples for the week.The sample control failed.The customer discarded the run data and did not report any patient results.The samples were re-run on a second instrument with no issue.Example data was requested from the customer but was not provided.

• 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: 11609424
• Report Number: 1061932-2021-00046
• Device Sequence Number: 17060577
• Product Code: OYE
• UDI-Device Identifier: 15099590515522
• UDI-Public: (01)15099590515522(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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): 04/01/2021

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: 03/09/2021
• 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