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 10/05/2022

Event Type  malfunction  

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 forward scatter (fs), and fl5 positions.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 customer reported signal drift at the forward scatter (fs), and fl5 positions on their fc 500 flow cytometer while running quality control.There was no report of 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 147th avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 3053802874
• MDR Report Key: 15594938
• MDR Text Key: 307079048
• Report Number: 1061932-2022-00064
• 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,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/13/2022

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
• 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
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 012-0108/2018-001C
• Patient Sequence Number: 1