MAUDE Adverse Event Report: BECKMAN COULTER, INC. UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 600 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	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Service was scheduled.The field service engineer (fse) inspected the instrument and confirmed the reported issue.The fse replaced the rear blood detector, the flow cell, the mals sensor and the sam ribbon cable to resolve the issue.The fse ran controls that passed to verify the repairs.Section a2, a4, and a5: information not provided by customer.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported that their dxh600 hematology instrument generated erroneous platelet (plt), hemoglobin (hgb), wbc and rbc results with partial aspiration (p) errors on patient samples.Erroneous patient results were not reported out of the laboratory.There was no report of death, serious injury, or change to treatment associated with this event.

• Brand Name: UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 20353476
• Report Number: 1061932-2024-00013
• Device Sequence Number: 6261766
• Product Code: GKZ
• UDI-Device Identifier: 15099590192242
• UDI-Public: (01)15099590192242(11)170915
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• 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
• Report Date (Section B): 10/02/2024

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 600 HEMATOLOGY SYSTEM
• Device Catalogue Number: B23858
• Device Lot Number: N/A
• 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: 09/04/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2017
• 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