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 Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported getting low lymphocyte count on the navios flow cytometer due to poor ¿contacts¿.The customer was analyzing samples for cd34+ counts.The decrease in lymphocyte count resulted in decreased cd34+ counts.The field service engineer (fse) went to the customer site and performed troubleshooting to identify the cause of the low lymphocyte counts on the navios ex instrument.The fse performed various checks and determined there was no malfunction of the instrument.The fse used a new vial of properly mixed flow count to process on the instrument.Testing a sample from each of the two vials of flow count confirmed that the original one (in use when the problem occurred) had increased concentration.It was determined that the increase in concentration was due to improper mixing.Instructions for mixing flowcount are provided in the flowcount instructions for use (pn: (b)(4)).Patient data was not provided.Bec internal identifier case: (b)(4).
Event or Problem Description
The customer reported getting low lymphocyte count on their navios ex flow cytometer system.Erroneous patient results were generated but were not reported out of the laboratory.There was no change or effect to patient treatment in connection to the event.There was no report of injury or biohazard exposure to open wounds or mucous membranes.
Additional Manufacturer Narrative
Follow up 01: d3 manufacturer name, city and state has been updated to the correct information.Bec internal identifier: (b)(4).

• 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; lismeehan CA ; EI
• MDR Report Key: 9649898
• Report Number: 1061932-2020-00010
• Device Sequence Number: 14181332
• Product Code: OYE
• UDI-Device Identifier: 15099590677466
• UDI-Public: (01)15099590677466(11)190729
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K162897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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 EX 10 COLORS/3 LASERS
• Device Catalogue Number: B80910
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1