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

Model Number	XN-10
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient in (b)(6) presented to the hospital and a sample was collected for analysis.The sample generated a false high platelet (plt) result.The patient was sent home.The patient returned to the hospital with a nosebleed approximately one hour later and another sample was collected.The recollected sample generated a critical low plt value.Per the user, the patient experienced a delay of necessary plt transfusion due to the erroneous high plt result reported.No serious injury or harm to the patient due to the delay in treatment was reported.
Additional Manufacturer Narrative
The samples were judged "positive" with multiple flags, including the thrombocytopenia flag.The sysmex xn-1000 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 analyzer alerted the operator to possible sample abnormality requiring verification prior to reporting of results.The initial analysis was limited to cbc+diff testing.Analysis through additional channels exposes the sample to more of the proprietary algorithms within the analyzer, and may better discern between cell and particle types.Chapter 15 - technical information, section 15.4.2 - analysis parameters and channels, discusses the differences between the channels.The plt-f channel is used to measure platelets with accuracy; primarily low platelet counts.Settings can be changed to indicate when the sample is to be repeated using the plt-f channel.Root cause is undetermined.No analyzer deficiency was identified.The user failed to verify suspect results.

• 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: 14748454
• Report Number: 1000515253-2022-00008
• Device Sequence Number: 17411695
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)190221
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

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-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2019
• 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 Sex: Female