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	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) determined that the tarpon amp board at the forward scatter (fs) position was defective.The failed board is a revision gd tarpon amp board.The fse replaced the board at the identified position to resolve the problem.Bec internal identifier- (b)(4).
Event or Problem Description
The customer reported unstable flow count rates (fcrs) on their fc 500 flow cytometer.Erroneous patient results were generated but were not reported out of the laboratory.The amp board failure caused the negative population to be placed in the wrong position on the histogram.There was no reported death, injury or change to patient treatment.

• Brand Name: FC 500 FLOW CYTOMETER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 12419091
• Report Number: 1061932-2021-00107
• Device Sequence Number: 20005532
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1