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	10/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information was not provided by the customer.The application support specialist worked with the customer but was not able to identify an instrument malfunction.The issue only occurred with a specific batch of samples.The customer did not call back to report a recurrence of this event.Bec internal identifier case: (b)(4).
Event or Problem Description
The customer reported discrepant cd4 counts on the aquios cl.Results were reviewed and not released 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: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12828130
• Report Number: 1061932-2021-00153
• Device Sequence Number: 1362109
• Product Code: OYE
• UDI-Device Identifier: 15099590225889
• UDI-Public: (01)15099590225889(11)180727
• 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): 11/16/2021

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: 10/21/2021
• Initial Report FDA Received Date: 11/17/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown