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

Model Number XN-10

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2022

Event Type  Injury  

Manufacturer Narrative

The initial analysis of sid (b)(4) was judged "negative" with no ip messages.The sysmex xn-9100 instructions for use (ifu), chapter 11: checking detailed analysis information (data browser), section 11.5: 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.Chapter 11 further details ip message types, meanings, and judgment methods, and provides the default ip message settings.The user-defined setting for "thrombocytopenia" was not engaged at the default setting of plt value <60 x 10^3/ul.The initial analysis of sid (b)(4) generated a plt value of 49 x 10^3/ul.Had the analyzer been set to the manufacturer's default settings the suspect analyses would have been judged "positive" indicating the need for further review of the sample prior to result reporting.Chapter 15: technical information, section 15.2: system limitations and interfering substances, notes: "compromised samples, such as those not properly collected, stored, transported, or contain clots may cause misleading results.Always use good laboratory practices for inspecting specimens for acceptability and verifying results." a pre-analytical sample issue caused this event.The user is responsible for verifying sample integrity prior to analysis.No product deficiency was identified.

Event Description

The sample was analyzed generating a falsely decreased platelet (plt) result.The result was released to the medical team.Based on the falsely decreased plt result, the patient received an unnecessary head computed tomography (ct) scan.No patient harm was reported due to the head ct.This event is being reported because of the unnecessary diagnostic exposure from the head ct.

• Brand Name: SYSMEX XN-10
• Type of Device: 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: 14708108
• MDR Text Key: 294934172
• Report Number: 1000515253-2022-00005
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)181210
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Sex: Female