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 10/22/2021

Event Type  malfunction  

Event Description

The customer reported amp board errors at the fl4 location of their fc 500 flow cytometer.There was no report of death, injury, or change to patient treatment as a result of this event.

Manufacturer Narrative

Section a patient information is not applicable.There was no impact to patients as a result of this event.The field service engineer (fse) was at the customer site and confirmed that the tarpon amp board at the fl4 channel location was functioning as expected the fse tested the instrument using flow-check and reported that channels fl1, fl2, fl3, fl4 and fl5 were stable but signal gaps persisted at the ss channel location.The fse replaced the tarpon amp board at the ss location.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 case: (b)(4).

• 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 147th avenue; miami FL 33196 2031
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12828143
• MDR Text Key: 283269652
• Report Number: 1061932-2021-00154
• 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: GM
• PMA/PMN Number: K071681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• 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: 10/22/2021
• 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