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

Model Number	XN-10
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The sample was analyzed and a false low platelet (plt) result was reported.The sample was judged negative, and no smear review was performed.It was alleged the patient received one unnecessary dose of 40 mg prednisone treatment based on the erroneous plt result.The following day, a manual smear of the sample revealed presence of plt clumps.The prednisone treatment was discontinued after the plt clumps were noted.No negative patient impact from the treatment was reported.
Additional Manufacturer Narrative
Suspect analyses were judged "negative" with no interpretive program (ip) messages alerting the operator to possible sample abnormalities.The sysmex xn-2000 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.Any flag not generated indicates the criteria defined were not met.User-defined settings will impact sample judgement and generation of flags.The user-defined setting for "thrombocytopenia" is a plt result of less than 20 x 10^3/ul.The default setting for "thrombocytopenia" is a plt value 60 x 10^3/ul.All sample analyses generated a plt value of 60 x 10^3/ul.Had the analyzer been set to the manufacturer's recommended default settings, the sample would have been judged "positive" indicating the need for further review of the sample prior to result reporting.The possibility of plt clumps are judged from the presence of plt clumps on the wnr, wdf, and plt-f scattergrams.All sample analyses were limited to either plt or cbc/diff only 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 measurement channels.The plt-f channel is used to measure platelets with accuracy; primarily low platelet counts.The user is able to change settings to indicate when the sample is to be repeated using the plt-f channel.Users are informed of situations in which results may be affected in the ifu, chapter 15 - technical information, section 15.2 system limitations and interfering substances.For platelets, a warning is stated: "if any of the following are present, the system may erroneously report a low platelet count: possibility of plt clumps, pseudothrombocytopenia (caused by edta typically), giant platelets." the investigation determined the analyzer performed as designed.There was not enough activity in flagging areas for plt-specific suspect flags to trigger.The data suggests patient specific abnormality/interference causing plt clumping caused this event.

• 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: 16590241
• Report Number: 1000515253-2023-00003
• Device Sequence Number: 11518481
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)190903
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/22/2023

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: 03/13/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2019
• 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: 63 YR
• Patient Sex: Male