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

Model Number	XN-20
Medical Device Problem Codes	Low Test Results (2458); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All analyses for all samples were judged "positive", with multiple interpretive program (ip) messages indicating the possibility of sample abnormality and that review was necessary prior to reporting.The sysmex xn-3000/xn-3100 instruction 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."when analysis data is analyzed in the ipu, information that supplements the positive/negative sample judgment appears in the [data browser] screen.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 user is cautioned that: "a "positive" or "error" judgment indicates the possibility of an abnormality." "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." 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.All analyses for all sample results generated plt-i results with an asterisk, indicating the need for further review of the sample prior to resulting.The xn-20 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.Values obtained in cbc analysis are used in conjunction with other clinical signs and symptoms to determine patient diagnosis and treatment.Good laboratory practice requires that a system be in place for confirming and reporting critical values and/or significant changes in the patient test results (delta checks, previous result reviews, verification by another method, peripheral smear examination, etc.).The data suggests a patient/specimen specific abnormality contributed to the event.The analyzer alerted the user to sample abnormalities by flagging analysis results.No analyzer deficiency was identified.
Event or Problem Description
A patient in (b)(6) received an unnecessary platelet (plt) transfusion based on erroneous low plt results generated by the analyzer.There was no harm reported due to the unnecessary transfusion.

• 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: karen bieletzki ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439710
• MDR Report Key: 13506724
• Report Number: 1000515253-2022-00002
• Device Sequence Number: 14783645
• Product Code: GKZ
• UDI-Device Identifier: 04987562424221
• UDI-Public: 0104987562424221
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 02/10/2022

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: 01/16/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2019
• 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: 2 WK
• Patient Sex: Male