MAUDE Adverse Event Report: BECKMAN COULTER IRELAND 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	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided by the customer.The field service engineer (fse) was onsite and found that the fl4 channel was intermittently dropping out while running samples.To resolve the issue the fse replaced the signal conditioner and amplifier (sca) board at the affected location (fl4).The fse ran qc to verify proper operation of the unit.Bec internal identifier - case-(b)(4).
Event or Problem Description
The customer reported unexpected positive (high) results for cd138 on their navios ex flow cytometry instrument.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: NAVIOS EX FLOW CYTOMETER
• 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: 11897783
• Report Number: 1061932-2021-00070
• Device Sequence Number: 14302918
• Product Code: OYE
• UDI-Device Identifier: 15099590677466
• UDI-Public: (01)15099590677466(11)180713
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

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: 05/05/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1