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	12/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The beckman (bec) customer technical support (cts) connected to the instrument remotely and confirmed no errors or issues were present at the time the patient sample was processed.The cts suggested running quality control tests to ensure the unit was functioning properly.The customer reported that during the collection of the sample, it was suspected of being contaminated and they did not suspect instrument malfunction.There was no malfunction identified.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported their dxh 900 hematology instrument (part c11478, serial number (b)(6) generated an erroneous hemoglobin (hgb) result of 4.2 g/dl from a suspected contaminated sample instead of the correct value of approximately 12 g/dl leading to the patient receiving an unnecessary blood transfusion.All complete blood count (cbc) parameters were found to be erroneous.It was confirmed that the admimistration of the transfusion did not have an adverse impact on the patient.The customer reported that during the collection of the sample, it was suspected of being contaminated and they did not suspect instrument malfunction.Patient data was provided for review.All cbc parameter results, [white blood cell (wbc), red blood cell (rbc), hematocrit (hct), mean corpuscular volume (mcv), mean corpuscular hemoglobin concentration (mchc), mean corpuscular hemoglobin (mch), red cell distribution width (rdw), platelet (plt) and mean platelet volume (mpv)], generated from the suspected contaminated sample were erroneous.

• 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: 24196290
• Report Number: 1061932-2026-00003
• Device Sequence Number: 18658306
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)230109
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/27/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown