MAUDE Adverse Event Report: BECKMAN COULTER NAVIOS EX 10 COLOR 3 LASER 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	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported samples show unusual patterns on the navios ex 10 colors/3 laser flow cytometer due to a broken sheath harness.The results were rejected as questionable/erroneous due to the histogram patterns.The customer was running a laboratory designed test (ldt).There were questionable patient results generated but not reported out of the laboratory.There was no adverse event, change or effect to patient treatment in connection to the event.The results were rejected as questionable/erroneous due to the histogram patterns.The customer was running a laboratory designed test (ldt).The data provided by the customer confirms the unusual histogram patterns.This pattern could be interpreted as a false negative or generate an erroneous value.The customer followed labeling instructions and called to report the issue.The potentially erroneous results were not reported out of the laboratory quality control was within specifications.The issue manifested after the qc run.
Additional Manufacturer Narrative
The customer reported that the sheath harness was broken and that the internal tank was not filling automatically.The customer was manually filling the internal tank.The customer technical support (cts) ordered a sheath harness and scheduled service.The filed service engineer (fse) confirmed that the sheath harness was broken and that internal sheath level errors were generated by the system.The fse also found that the vortexer was not working properly.The fse replaced the spring adjustable sheath harness and the mcl lifter motor resolve the issue.Both part failures can contribute to questionable/erroneous results.Labeling: per the navios instructions for use (pn: a96247ae), the user is instructed to and/or advised of: there is a risk of reporting incorrect results.Data displays used to arrive at the test result for light scatter patterns, antibody staining profiles, and all gates and boundaries should be reviewed by a laboratory professional when interpreting the data.If results are suspect, follow your laboratory's procedures to resolve.Bec internal identifier - (b)(4).

• Brand Name: NAVIOS EX 10 COLOR 3 LASER FLOW CYTOMETER
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.
• Manufacturer (Section D): BECKMAN COULTER; 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: 17911689
• Report Number: 1061932-2023-00106
• Device Sequence Number: 18023972
• Product Code: OYE
• UDI-Device Identifier: 15099590677466
• UDI-Public: (01)15099590677466(11)220418
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183592
• 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): 10/11/2023

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: 09/18/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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