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

Model Number	TN FC500 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	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The field service engineer (fse) reported signal shift at fl2 and fl3 positions on the fc500 flow cytometer while running flow check control while servicing the instrument.There was no report of death, injury, or change to patient treatment as a result of this event.There were no erroneous patient results generated.
Additional Manufacturer Narrative
Patient information is not applicable.There was no impact to patients as a result of this event.While the fse was servicing the instrument for an unrelated issue, he observed that the tarpon xl amp assembly at the fluorescence channel (fl2 and fl3) positions was defective.To resolve the issue the fse replaced the board at the identified positions.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).
Additional Manufacturer Narrative
Follow up report 01- correction field g3 date received by manufacturer revised to reflect correct date of awareness by bec.Bec internal identified - (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 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 15982324
• Report Number: 1061932-2022-00075
• Device Sequence Number: 6960534
• Product Code: GKZ
• UDI-Device Identifier: 15099590572839
• UDI-Public: (01)15099590572839(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Modification/Adjustment,Replace,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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 FLOW CYTOMETER 100-240V 50/60HZ
• Device Catalogue Number: 626553
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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
• Patient Sex: Unknown