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	06/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
While at the customer site performing preventive maintenance on the customer's fc 500 flow cytometer, the field service engineer (fse) observed that the tarpon amp boards at the fl3 and fl4 were generating errors.There was no report of erroneous patient results associated with the event.There was no reported death, injury or change to patient treatment.
Additional Manufacturer Narrative
Patient information is not applicable.There was no impact to patients as a result of this event.The field service engineer (fse) was on site and confirmed what the customer reported.To resolve the issue the fse replaced the tarpon amp boards at the affected locations (fl3 and fl4).Upon further review, this complaint was reassessed and will be reported late as it was determined that this event was in scope of the tarpon amp board recall.Bec is filing an mdr for this event based on the fda classification of the (b)(6) 2018 urgent medical device recall as a class i recall on (b)(6) 2018 (recall number z-0471-2019 for fc 500; recall number z-0472-2019 for epics xl/xlmcl).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 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12791767
• Report Number: 1061932-2021-00145
• Device Sequence Number: 20248355
• Product Code: GKZ
• UDI-Device Identifier: 15099590572822
• UDI-Public: (01)15099590572822(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Notification,Modification/Adjustment,Replace
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 11/10/2021
• 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