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

Model Number	TN DXH 800HEMATOLOGY 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	01/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The beckman (bec) customer technical specialist (cts) assisted with the customer's reported issue.The cts performed troubleshooting, and no instrument malfunction was identified.The cts stated that all quality control results were within range.The (bec) application specialist contacted the customer and confirmed that the instrument is working in its validated state.The customer was also provided with training on the appropriate handling of flagged results.No repair work was performed.The bec medical director reviewed the available information and provided the following assessment: based on the information available, it could not be confirmed that the transfusions administered were unnecessary given the patient¿s medical history.The results generated r flags, which alerted the customer that the results required review; however, the operator released the results without performing a manual count to verify them.Per instruction for use (ifu) part number b26647, current rev beckman coulter recommends using all available flagging options to optimize the sensitivity of instrument results.All flagging options include reference intervals (h/l), action and critical limits, definitive, suspect and system messages, parameter codes, delta checks, decision rules, and system status and exception messages.Beckman coulter recommends avoiding the use of single messages or outputs to summarize specimen results or patient conditions.System messages: a system message indicates an event occurrence that may affect the operation of the system or the quality of the results or requires operator intervention.Bec internal identifier -(b)(4).
Event or Problem Description
The customer reported that their dxh800 hematology instrument generated erroneously low platelet (plt) results for a patient with a malignant hematopathy (myelodysplasia).The initial plt result was approximately 10 g/l and when the patient under went tests in another laboratory the results was above 20g/l.The erroneous results were reported outside of the laboratory.Because of their pre-existing condition, the patient received transfusions based on the plt result.When the plt value is >20 g/l it does not lead to transfusion, when the results is 10 g/l, the patient is systematically transfused.The patient was systematically transfused based on the dxh800 results of approximately 10 g/l.The customer stated that this difference represents a significant clinical discrepancy.The patient received multiple transfusions; however, no adverse effects or clinical complications related to the transfusions were observed.The patient data provided by the customer shows that the results were flagged with 'r' flags that prompt the operator to review the results before releasiing them out of the laboratory.The flagged results were released without additional verification.

• Brand Name: UNICEL DXH 800 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: 24310432
• Report Number: 1061932-2026-00007
• Device Sequence Number: 4942180
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)151204
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193124
• 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): 02/10/2026

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 800HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: B24802
• 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: 01/14/2026
• Initial Report FDA Received Date: 02/10/2026
• Date Device Manufactured: 12/04/2015
• 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