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

Model Number	TN FC500 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	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Serivce is scheduled to be at the customer site on 20-sept- 2022.A follow up will be provided once new information becomes available.Bec internal identifier - (b)(4).
Event or Problem Description
The customer that the plots are coming off the baseline at the fl2 position of their fc 500 flow cytometer.There was an intermittent upward signal shift at the fl2 position causing erroneous results for their leukemia/lymphoma ldt.The customer discarded the results and re-ran the samples on a different instrument to obtain correct results.There was no report of death, injury, or change to patient treatment as a result of this event.
Additional Manufacturer Narrative
The customer reported that the plots are coming off the baseline at the fl2 position on the fc500 when running their ldt (laboratory designed test) for leukemia/lymphoma.There was an intermittent upward signal shift at the fl2 position causing erroneous results for their leukemia/lymphoma ldt.The customer discarded the results and re-ran the samples on a different instrument to obtain correct results.The customer was advised by the field applications specialist to call customer technical support and request replacement of the tarpon amp board.With the information available at the initial assessment two technical support subject matter experts reviewed the available data and information provided by the customer and both indicated that the event does not appear related to a tarpon board malfunction.The field service engineer (fse) was at the customer site on 20-sep-2022 and replaced the tarpon amp board at the affected location (fl2).Bec internal identifier - (b)(4).
Event or Problem Description
The customer that the plots are coming off the baseline at the fl2 position of their fc 500 flow cytometer.There was an intermittent upward signal shift at the fl2 position causing erroneous results for their leukemia/lymphoma ldt.The customer discarded the results and re-ran the samples on a different instrument to obtain correct results.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: FC 500 FLOW CYTOMETER
• Common Device Name: 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 ; 7149613625
• MDR Report Key: 15442246
• Report Number: 1061932-2022-00059
• Device Sequence Number: 14953982
• Product Code: GKZ
• UDI-Device Identifier: 15099590572839
• UDI-Public: (01)15099590572839(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K071681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown