MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE SYSMEX XN-20; AUTOMATED HEMATOLOGY ANALYZER

Model Number	XN-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer is a user of a sysmex xn-3100 automated hematology system, encompassing two xn-20 automated hematology analyzers, (b)(6).Per the reporter, unnecessary treatment was issued based off the low white blood cell (wbc) result obtained from the analysis of sid (b)(6) with xn sn (b)(6) on november 16, 2023, at 12:34:42.A new sample, sid (b)(6), was collected when the filgrastim medication was stopped, 3 hours after administration initiation.It is unknow what set of results was provided to the clinical team for sid (b)(6), however, the low wbc counts reported raised suspicion and the clinical team requested a blood smear review for confirmation.The smear review confirmed the reported wbc results to be erroneous for both samples.The results of the smear review and the values for the correct wbc results were not provided by the reporter.The suspect analysis of sample id (sid) (b)(6) was judged "positive" and generated interpretive message (ip) flags to alert the operator 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 message are categorized as "positive" or "negative" based upon preset criteria, some of which are user-defined.The system bases judgments on comprehensive surveys of numerical data, particle-size distributions, and scattergrams.Flags and messages, communicated through ip messages, indicate the analyzer's findings and notify the user of possible sample specific abnormalities.The suspect analysis of sid (b)(6) generated an action message "difference between wnr and wdf" was generated alerting the operator of a discrepancy in results between the wnr and wdf analysis methodologies.Chapter 10 - checking analysis data (sample explorer), section 10.1.2 - analysis data list, explains items that can be displayed on the analysis data list.Common items are items displayed in the left section of the analysis data list on all tabs.Action messages and error/rule comments are common items which indicate the analysis results need to be reviewed and reanalyzed.The suspect analysis of sid (b)(6) generated results that were accompanied by an asterisk [*], indicating the data to be unreliable.Chapter 10 - checking analysis data (sample explorer), section 10.1.4 - numerical data of the analysis results, describes the masks and marks that may be added to analysis data.Masks and marks indicate an abnormality in the analysis data.An asterisk [*] indicates the data is unreliable, while dashed lines [----] indicate an error occurred, and the value cannot be displayed.The analyzer alerted the operator to possible sample abnormality for the suspect analysis of sid (b)(6).The operator failed to verify accurate results prior to result reporting.Four sample analyses were executed for sid (b)(6) prior to the suspect analysis.All four analyses were judged "positive", generating ip message flags and an error 155 "wnr sampling error".Chapter 14 - troubleshooting, informs of error messages, their probable cause, and actions to take to resolve the issue.For the wnr sampling error, the following is indicated: probable cause: 1) the density of the sample is inconsistent.2) the flowcell has suddenly become clogged.Actions: 1) click [accept] in the help dialog box, mix the sample well, and then re-analyze.2) click [accept] in the help dialog box.Once the device is in ready state, rinse the flowcell.For the details on rinsing the flowcell, see chapter 13.([?]p.287 "chapter 13: 13.3.9 rinse flowcell").It is unknown if the customer performed the actions indicated as directed.At the time of this assessment, no analyzer malfunction has been identified.However, the event was escalated to the manufacturer, sysmex corporation japan, for further investigation.
Event or Problem Description
In the united kingdom, a patient received an unnecessary dose of filgrastim due to a low white blood cell (wbc) result generated by xn-20 sn 15325.No harm to the patient was reported as a result of the unnecessary treatment.
Additional Manufacturer Narrative
Sysmex corporation japan completed the investigation.No analyzer deficiency was identified.Data suggests a sample specific interference contributed to anomaly in the wnr channel.The analyzer performed as designed, alerting the operator to the need to verify results.

• Brand Name: SYSMEX XN-20
• 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: 18372160
• Report Number: 1000515253-2023-00009
• Device Sequence Number: 7767132
• Product Code: GKZ
• UDI-Device Identifier: 04987562424221
• UDI-Public: (01)04987562424221(11)200702
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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-20
• Device Catalogue Number: AE797961
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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: 73 YR
• Patient Sex: Female