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	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the populations at the fl4 position on their fc 500 flow cytometer were not being gated correctly causing erroneous cd34+ results.Erroneous results were not reported out of the lab.There was no report of death, injury, or change to patient treatment as a result of this event.
Additional Manufacturer Narrative
The field service engineer (fse) was on site and confirmed that the tarpon amp board and signal conditioner at the fl4 position was defective.The failed board is revision gd.The amp board failure caused failure of the auto-gating at the fl4 position causing erroneous cd34+ results.The customer manually re-gated all impacted runs to obtain correct results.The fse replaced the board at the identified position to resolve the problem.Bec internal identifier - case(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 ave; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 15306968
• Report Number: 1061932-2022-00054
• Device Sequence Number: 2658064
• Product Code: GKZ
• UDI-Device Identifier: 15099590572839
• UDI-Public: (01)15099590572839(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: 08/22/2022
• Initial Report FDA Received Date: 08/26/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown