MAUDE Adverse Event Report: KAKOGAWA FACTORY SYSMEX XN-430; AUTOMATED HEMATOLOGY ANALYZER

Model Number	XN-430
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All sample analyses were judged "positive".The xn-530/xn-430/xn-330 troubleshooting manual, chapter 5 - ip messages, section 5.1 overview of ip messages states: "when analysis data is analyzed, information that supplements the positive/negative sample judgment appears in the [data browser] screen.Results without an analysis error are classified as positive or negative based on preset criteria.The system judges flags for analysis data based on comprehensive surveys of numerical data, distributions and scattergrams, and provides easily to understand messages indicating the results.These messages are referred to as "ip (interpretive program) messages".The user is cautioned: "a positive or error judgment indicates the possibility of an abnormality.It is not a diagnosis of the patient.If a positive or error judgment occurs, check the data and repeat the analysis, or examine carefully in accordance with the protocol of your laboratory".It is the responsibility of the operator to verify the produced results prior to reporting to the clinician.The user facility does not perform smear reviews.The post treatment sample had a smear review performed by a reference lab, which revealed the presence of plt clumps.The xn-530/xn-430/xn-330 general information manual, chapter 5 - instrument specifications, section 5.2 - system limitations and interfering substances, informs the user: if any of the following conditions are present, the system may erroneously report a low platelet count: platelet aggregation, pseudothrombocytopenia, giant platelets.The analyzer performed as designed by alerting the operator to suspect sample abnormality via flagging.The patient appears to have a history of platelet clumping.Platelet clumping is a known interference with impedance platelet technology.No analyzer deficiency was identified.
Event or Problem Description
The user alleged the sample generated a false low platelet (plt) result, leading to unnecessary steroid treatment (dexamethasone).A post treatment sample was analyzed, generating a false low plt result.A manual smear was prepared of this sample, revealing the presence of plt clumps.There was no known negative impact from the administration of the steroid treatment for the involved patient provided.

• Brand Name: SYSMEX XN-430
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): KAKOGAWA FACTORY; 314-2 kitano; noguchi-cho, kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer (Section G): KAKOGAWA FACTORY; 314-2 kitano; noguchi-cho, kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer Contact: william haste ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439459
• MDR Report Key: 15787837
• Report Number: 1000515253-2022-00009
• Device Sequence Number: 5528560
• Product Code: GKZ
• UDI-Device Identifier: 04987562434541
• UDI-Public: (01)04987562434541(11)220221
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182389
• 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): 11/11/2022

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-430
• Device Catalogue Number: CL032175
• 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: 11/04/2022
• Initial Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2022
• 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: 69 YR
• Patient Sex: Female