MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. 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	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer ran the patient samples and then evaluated them by using list mode playback.The incorrect or inaccurate results were identified and discarded.The mixer intermittently failed to operate.The field service engineer (fse) replaced the mcl lifter motor to resolve the issue.Bec internal identifier - case (b)(4).
Event or Problem Description
The customer reported that the mixer sometimes stops on the navios 10 color/3 laser flow cytometer.Erroneous patient results were generated but 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 INC.; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• MDR Report Key: 10120223
• Report Number: 1061932-2020-00087
• Device Sequence Number: 1848292
• Product Code: OYE
• UDI-Device Identifier: 15099590515522
• UDI-Public: (01)15099590515522(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130373
• 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
• Report Date (Section B): 06/03/2020

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 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: 05/13/2020
• Initial Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1