MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE SYSMEX XN-10; AUTOMATED HEMATOLOGY ANALYZER

Model Number	XN-10
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All analyses were judged "positive" alerting the user to possible sample abnormality.The sysmex xn-3000/3100 instructions for use (ifu), chapter 11 - checking detailed analysis information (data browser), section 11.6 - ip messages, details the method in which the analyzer conveys its findings: "results without an error messages are classified into positive/negative based on the preset criteria.The system bases its judgments on comprehensive surveys of numerical data, particle size distributions, scattergrams, and provides easily-to-understand flags/messages indicating the instruments findings.These flags/messages are referred to as "ip (interpretive program) messages." the ifu cautions: "a "positive" or "error" judgment indicates the possibility of an abnormality.It is not a diagnosis of the patient.If a "positive" or "error" judgment occurs, check the data and repeat the test or examine carefully in accordance with the protocol of your laboratory.Ip messages are only intended for use in the clinical laboratory and are not for patient diagnosis.Ip messages provide notification of the possibility of a specific sample abnormality based on examination of the analysis data." during the investigation, the customer reported visual inspection of the remaining sample volume post analysis identified that the sample tube was nearly empty.The customer suspected inadequate sample volume prior to analysis.Chapter 9 - analyzing samples, section 9.2.1 sample types and handling, details the required sample volume for a whole blood specimen in sampler analysis mode is 1 ml.Chapter 9 - analyzing samples, section 9.5 - performing a system analysis (sampler analysis), cautions: "please ensure that sample tubes are filled and used in accordance with the manufacturer's package insert." chapter 15 - technical information, section 15.2 - system limitations and interfering substances, notes: "compromised samples, such as those not properly collected, stored, transported, or contain clots may cause misleading results.Always use good laboratory practices for inspecting specimens for acceptability and verifying results." a service engineer was dispatched to verify analyzer performance.No analyzer deficiency was identified.The event was escalated to the manufacturer, sysmex corporation japan (s-corp) who provided the following assessment: across all three cases, the identified causes were related to pre-analytical sample handling errors, specifically insufficient sample mixing and insufficient sample volume.The xn 10 detected potential sample abnormalities and appropriately notified the operator through ip messages and positive/negative judgments.Data suggests a preanalytical sample issue contributed to the event.The analyzer performed as designed, flagging suspect results for further review.
Event or Problem Description
The patient received two unnecessary packed red blood cell transfusions based on a low hemoglobin (hgb) result generated by the analyzer.There was no report of negative patient impact due to the unnecessary transfusions.

• Brand Name: SYSMEX XN-10
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer (Section G): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer Contact: william haste ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439459
• MDR Report Key: 24381746
• Report Number: 1000515253-2026-00001
• Device Sequence Number: 13326304
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)180921
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/18/2026

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: XN-10
• Device Catalogue Number: AP795756
• 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: 01/29/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2018
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 39 KG