MAUDE Adverse Event Report: BECKMAN COULTER INC. UNICEL DXH 520 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 520 CP HEMATOLOGY INSTRUMENT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the dxh 520 analyzer (product number b40602, serial number (b)(6) generated erroneous high hemoglobin (hgb) results for one patient sample.Although the hgb result was 11g/dl, the patient was sent to the hospital based on physical assessment.A gasometer reading was carried out at the hospital and the hgb result was 4 points lower than the original hgb result.The patient was administered a transfusion at the hospital.Additional details regarding the transfusion were requested but the customer did not provide anymore information on the basis of patient confidentiality.It is unknown if the patient has a preexisting condition or was sent to the hospital to have the transfusion administered.It was confirmed that there was no impact to the patient and no delay to patient treatment as a result of the erroneous hgb result.On site service was scheduled.
Additional Manufacturer Narrative
A beckman (bec) field service engineer (fse) inspected the instrument and did not identify an instrument malfunction.The fse ran controls and repeatability which all passed verifying that the instrument was running within specifications.The assignable cause may be sample related.The investigation did not identify a confirmed instrument malfunction or analytical error.Bec internal identifier - (b)(4).

• Brand Name: UNICEL DXH 520 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER INC.; lismeehan; o callaghans mills, co clare ; EI
• Manufacturer (Section G): BIT GROUP FRANCE; rue de la valsere; parc euromedicine ii; montepellier cedex 34090 ; FR 34090
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 24837944
• Report Number: 1061932-2026-00009
• Device Sequence Number: 21230979
• Product Code: GKZ
• UDI-Device Identifier: 15099590679781
• UDI-Public: (01)15099590679781(11)210115
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K181475
• 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): 04/09/2026

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 520 CP HEMATOLOGY INSTRUMENT
• Device Catalogue Number: B40602
• 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: 03/12/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• 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