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

Model Number	TN, XL FLOW CYTOMETER 100-240V, 50/60HZ
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was on site and confirmed what the customer reported.To resolve the issue the fse replaced the tarpon amp board at the fl2 location.Bec is filing an mdr for this event based on the fda classification of the 08 jan 2018 urgent medical device recall as a class i recall on 20 nov 2018 (recall number z-0471-2019 for fc 500; recall number z-0472-2019 for epics xl/xlmcl).Bec internal identifier - case-(b)(4).
Event or Problem Description
The customer reported a signal drift on their epics xl flow cytometry systems.There was no report of death, injury, or change to patient treatment as a result of this event.
Event or Problem Description
The customer reported a signal drift on their fc 500 mpl flow cytometer.
Additional Manufacturer Narrative
The field service engineer (fse) had originally documented their debrief on the incorrect instrument ( epics xl flow cytometry systems), as the investigator gathered information for their investigation the issue was identified and the event was confirmed to have happened on an fc500 mpl flow cytometer.This supplemental is being submitted to update/correct the instrument information submitted in the original report.All other event information remains the same.Follow up 01: corrected fields: b5 describe event - updated problem statement to reflect correct instrument name.D1 - brand name.D4 - catalog number, serial number, udi.G5 - 510k number.H9 - correction/removal reporting number.Bec internal identifier: (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
• MDR Report Key: 10083874
• Report Number: 1061932-2020-00076
• Device Sequence Number: 2899883
• Product Code: GKZ
• UDI-Device Identifier: 15099590572853
• UDI-Public: (01)15099590572853(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Remedial Action: Modification/Adjustment,Notification,Recall,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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, XL FLOW CYTOMETER 100-240V, 50/60HZ
• Device Catalogue Number: 626554
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2050012-0108/2018-001C
• Patient Sequence Number: 1