MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 800 HEMATOLOGY SYSTEM
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	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported approximately five patient samples recovered with high rbc and platelet (plt) results when cycled on their dxh800 instrument compared to alternate instrument.Mean corpuscular volume (mcv) results were also discordant between instruments.No erroneous results reported out of the laboratory.There was no report of death, injury, or change to patient treatment as a result of this event.Printouts of the event requested but not provided.Platelet and rbc suspect messaging could not be verified.Manual smear results were requested but was not available for review.The customer performed an aperture cleaning.However, the issue was not resolved.
Additional Manufacturer Narrative
The customer technical specialist (cts) verified the event thru pro service but was unable to resolve the issue remotely and service was scheduled for a customer visit.The field service engineer (fse) was at the customer site and observed that the blood sampling valve (bsv) was not rotating properly.The bsv pad misalignment caused pressure buildup disconnecting the tubing to the bsv.The fse replaced the bsv tubing and disassembled and cleaned the bsv resolving the event.Bec internal identifier: (b)(4).

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• 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 ave; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 17389977
• Report Number: 1061932-2023-00101
• Device Sequence Number: 8913948
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140911
• 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): 07/25/2023

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 DXH 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• 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: 07/13/2023
• Initial Report FDA Received Date: 07/25/2023
• 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