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 Consequences Or Impact To Patient (2199)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial evaluation of the issue was thought to be related to the database which was nearly full.Clearly space in the database did not resolve the problem.Re-installation of the navios v1.3 acquisition software (windows vista) and tetra for vista v1.0 also did not resolve the problem.The event was a result to use error.An individual technician was not properly mixing the flowcount beads prior to placing on the prepplus2 for sample preparation.The laboratory supervisor provided training to the technician on the proper technique for mixing flowcount to resolve the issue.The customer confirmed that adjustment of the flowcount mixing technique for the individual resolved the problem.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported tetra algorithm failures related to the cal region on the navios 10 colors/ 3 laser flow cytometer.Erroneous patient results may have been generated but were not reported out of the laboratory.There was no change or effect to patient treatment in connection to the event.

• 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: 10126717
• Report Number: 1061932-2020-00088
• Device Sequence Number: 1848249
• Product Code: OYE
• UDI-Device Identifier: 15099590515522
• UDI-Public: (01)15099590515522(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130373
• 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): 06/07/2020

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: 05/14/2020
• Initial Report FDA Received Date: 06/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1