MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC 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	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information available was not enough to determine the cause of the reported issue.The bec application specialist requested additional information from the customer multiple times but the information was not provided.The following is what is known: there was no issue with cd45 at the fl1 position, but the 45 positivity using clearllab could not be distinguished when it could be distinguished on another flow-cytometer.O the customer is using clearllab reagent and clearllab 10c panels.O pediatric b cell-all and plasma cell dyscasias were difficult to assess with cd45-ko(krome orange) o the instrument was passing flow-check pro and flow-set pro.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported that clearlab 45 population was too bright on all lost and all 4 tubes, and was not able to distinguish cd negative, moderate, bright at the fl10 position on the navios ex instrument.There was no report of erroneous results reported outside of the lab.There was no report death, injury or change to patient treatment.

• Brand Name: NAVIOS EX FLOW CYTOMETER
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• MDR Report Key: 12708852
• Report Number: 1061932-2021-00123
• Device Sequence Number: 4489411
• Product Code: OYE
• UDI-Device Identifier: 15099590677466
• UDI-Public: (01)15099590677466(11)180706
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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 EX 10 COLORS/3 LASERS
• Device Catalogue Number: B80910
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1