MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. AQUIOS CL FLOW CYTOMETRY SYSTEM; FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.

Model Number	TN AQUIOS CL
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	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided by the customer.The field service engineer (fse) confirmed the reported problem and after troubleshooting he found that the sample prep syringe was sticky.The fse replaced the sample prep valve and sample prep syringe which resolved the issue.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported that when running samples on the aquios cl flow cytometry system they obtained very low values and when they rerun the same sample, they obtained very high values.Erroneous results were generated but not reported out of the laboratory.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: AQUIOS CL FLOW CYTOMETRY SYSTEM
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• 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: 15543198
• Report Number: 1061932-2022-00063
• Device Sequence Number: 17767617
• Product Code: OYE
• UDI-Device Identifier: 15099590225889
• UDI-Public: (01)15099590225889(11)170825
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K141932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2022

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 AQUIOS CL
• Device Catalogue Number: B30166
• 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: 09/16/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• 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