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

Model Number	XN-10
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 02/10/2023, a sysmex service engineer (se) evaluated the analyzer and no deficiencies were found.Both analyses for sample id (sid): (b)(6) were judged "positive" with interpretive program (ip) messages alerting the operator to possible sample abnormality.The sysmex xn-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 laboratory-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 of possible sample specific abnormalities.Further verification of accurate results is recommended prior to reporting to the clinician.The initial analysis of sid: (b)(6) generated results with an asterisk [*].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.Chapter 9 - analyzing samples cautions the user: "please ensure that samples are mixed sufficiently before being placed on the analyzer." section 9.1 - types of analysis, informs the user: "manual analysis - in this analysis, the operator loads the sample tubes individually by hand.The operator also mixes the samples by hand." section 9.2.1 - sample types and handling, also cautions :"please ensure that samples are mixed sufficiently before being placed on the analyzer.Any delay in processing after mixing may lead to the production of incorrect results." the investigation determined that the analyzer performed as designed.Sid: (b)(6) was a low volume microtainer processed in manual mode.The data suggests that insufficient mixing prior to analysis may have contributed to this event; however, this could not be confirmed.
Event or Problem Description
The operator reported a falsely decreased hemoglobin (hgb) result to the medical team.The patient received an unnecessary red blood cell transfusion.No negative patient impact from the transfusion was reported.

• 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: 16373287
• Report Number: 1000515253-2023-00002
• Device Sequence Number: 12489559
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)200319
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2023

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-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: 02/03/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• 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: 12 DA
• Patient Sex: Unknown
• Patient Weight: 4 KG