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

Model Number TN FC500 FLOW CYTOMETER 100-240V 50/60HZ

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

To resolve the issue the fse replaced the tarpon amp board at the affected location (fs).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).

Event Description

The field service engineer (fse) observed signal instability at the fs (forward scatter) position of the customer's fc500 flow cytometer while performing a pm (preventative maintenance service).There was no report of erroneous patient results associated with the event.There was no reported death, injury or change to patient treatment as a result of this event.

• Brand Name: FC 500 FLOW CYTOMETER
• Type of Device: COUNTER DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s.kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147 avenue; miami FL 33196 2031
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12926971
• MDR Text Key: 283273919
• Report Number: 1061932-2021-00169
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590572839
• UDI-Public: (01)15099590572839(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2050012-0108/2018-001C
• Patient Sequence Number: 1