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	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided by the customer.The field service engineer (fse) was on site and confirmed what the customer reported, and found that the probe alignment was off.To resolve the issue the fse performed probe alignment and verified instrument operation.Bec internal identifier - case-(b)(4).
Event or Problem Description
The customer reported that the aquios cl is generating results with "plg count failed" notifications.Review of the data provided indicate that erroneously high cd4 results were generated for several samples.The results were not reported out of the lab.

• 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
• MDR Report Key: 11309407
• Report Number: 1061932-2021-00018
• Device Sequence Number: 11606504
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1