MAUDE Adverse Event Report: BECKMAN COULTER, INC. UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported discrepancies in the white blood cell (wbc) counts and nucleated red blood cell (nrbc) percentages in a newborn's test results on their dxh 900 hematology instrument (part number c1147, serial number (b)(6)).Erroneous results were reported outside the laboratory, and there was a reported impact to patient treatment.Because of the inaccurate values of the white blood cells (wbc), a pediatric patient was prescribed antibiotics that were not required.There was no report of an adverse impact due to the unnecessary medication.The customer stated that the instrument reported 148.8×10³/l wbc and 114.6 nrbcs/100 wbcs.However, the manual (reference) count showed a wbc of 70×10³/l and 164 nrbcs/100 wbcs.Samples and system flags were reviewed, and the instrument was found to display an "mcv interference wbc" flag.It was discussed with the customer that this flag indicates possible interference and advises review of the results.
Additional Manufacturer Narrative
The beckman (bec) customer technical specialist (cts) stated that quality control (qc) results for the instrument were within range and no instrument malfunction was identified.Onsite service was not scheduled for this event.After further communication with the customer, a new rule was created in the dxh 900 instrument to facilitate the operator's review of the wbc count when nrbcs are present.The rule is named "nrbc wbc estimate" and was created on (b)(6) 2025.This is the correct rule to use and is actively being used by the customer.Bec internal identifier - (b)(4).

• Brand Name: UNICEL DXH 900 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 ave.; miami FL 33196
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 23319366
• Report Number: 1061932-2025-00032
• Device Sequence Number: 4838627
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)220926
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TN DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: C11478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown