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	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer provided qc and patient data files for review to the customer technical support representative (cts) and the field application specialist (fas).The fas believes that a transient fluidics issue caused a collapse of the fs/ss population which caused erroneous results to be generated.The fas noted two possibilities for the random collapsed of the fs/ss populations: * tiny clots/fibers could have formed in the bone marrow sample tubes causing the side scatter to appear collapsed, which is what was observed in both the fs/ss and cd45/ss plots.*bubbles (related to sudden temperature changes) could have formed in the sheath fluid, which can also cause the side scatter to appear collapsed.These tiny clots/fibers can cause the side scatter to appear collapsed, which is what was seen in both the fs/ss and cd45/ss plots.Bubbles could have formed in the sheath fluid, which can also cause the side scatter to appear collapsed.Bubbles sometimes form when there is a spike and drop in temperature or after changing to a new sheath container that may have been stored in a place with a different temperature.The customer was informed that this can be prevented by assuring sheath fluid is at room temperature and to prime several times, initiate the cleanse icon, or run a cleanse panel.These actions will push and/or dissolve bubbles or tiny clots/fibers out of the sample line.(b)(4).
Event or Problem Description
The customer reported that cd45 populations looked abnormal when running their laboratory designed application on the navios ex 10 colors/3 laser flow cytometer.Three (3) patients, with 4 tubes in the panel, all had the fs (forward scatter) cut off and the monos/grans falling in the dim cd45 population area.The customer confirmed that one erroneous sample result was reported out of the laboratory due to cd34 negative with a cd33 positive results.The customer stated that erroneous results were reported out as suspected apml (acute promyelocytic leukemia) but no treatment was given to the patient based on the erroneous results.Once the issue was identified, the sample was re-run twice with confirming negative apml results.There was no reported 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.; 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: 15418236
• Report Number: 1061932-2022-00057
• Device Sequence Number: 2544899
• Product Code: OYE
• UDI-Device Identifier: 15099590677466
• UDI-Public: (01)15099590677466(11)180420
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K183592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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: B0910
• 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: 08/31/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• 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