MAUDE Adverse Event Report: BECKMAN COULTER FC 500 FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Model Number	TN,FC500 MPL FLOW CYTOMETER 100-240V,50/60HZ
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	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not applicable.There was no impact to patients as a result of this event.To resolve the issue the fse replaced the tarpon amp boards at the fl3 and fl4 locations.Bec is filing an mdr for this event based on the fda classification of the 08 jan 2018 urgent medical device recall as a class i recall on 20 nov 2018 (recall number z-0471-2019 for fc 500; recall number z-0472-2019 for epics xl/xlmcl).Bec internal identifier (b)(4).
Event or Problem Description
While on site for an unrelated service visit, the field service engineer (fse) observed tarpon amp board failures on the customer's fc 500 flow cytometer.There was no report of death, injury, or change to patient treatment as a result of this event.
Additional Manufacturer Narrative
Follow up 01: the date of event and date of awareness for this event if (b)(6) 2021.Bec internal identifier (b)(4).

• Brand Name: FC 500 FLOW CYTOMETER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92521
• MDR Report Key: 11467185
• Report Number: 1061932-2021-00032
• Device Sequence Number: 3632132
• Product Code: GKZ
• UDI-Device Identifier: 15099590572822
• UDI-Public: (01)15099590572822(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K071681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment,Notification,Recall,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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,FC500 MPL FLOW CYTOMETER 100-240V,50/60HZ
• Device Catalogue Number: 626554
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2050012-0108/2018-001C
• Patient Sequence Number: 1