MAUDE Adverse Event Report: SYSMEX CORPORATION SYSMEX XT-2000I; SYSMEX XT-2000I AUTOMATED HEMATOLOGY ANALYZE

Model Number XT-2000I

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

Review of the audit trail revealed the operator deleted quality control (qc) data points from the closed mode on (b)(6) 2019 and (b)(6) 2019, indicating the qc was out of range.The operator continued to analyze qc until it passed, and continued to run the analyzer.Failing qc would make the user aware of an issue to be resolved prior to using the analyzer for patient testing.  the sample was analyzed and repeated on (b)(6) 2019 (both times in the closed mode) with critical low hemoglobin (hgb) results, low mean cell hemoglobin concentration (mchc) results and negative judgement by the analyzer.Subsequent analyses of the same sample generated hgb and mchc results within normal range.Abnormal indices and the usual relationship between hgb/hct (mchc) may reflect a specimen issue or improper functioning in automated hematology analyzers.It was discovered the aspiration sensor was disabled at the time of the event.The sysmex xt-2000i instructions for use (ifu), chapter 11 - instrument setup, discusses the aspiration sensor."the results may be affected if the aspiration sensor is deactivated.Therefore please ensure that the sensor is activated [use] for routine operation." the aspiration sensor is used for monitoring blood aspiration status during sampler analysis.The sysmex xt-2000i ifu, chapter 16 - appendix, section 16.1 - ip message, details the method in which the analyzer conveys its findings."the ipu, displays and prints hematology information in a format designed to aid in the separation of positive and negative data results.All analyzed samples without analysis errors can be separated into a positive or negative category according to preset criteria.The system bases its judgments on comprehensive surveys of numerical data, particle size distributions, scattergrams, and provides easy-to-understand flags/messages indicating the instrument's findings.These flags/messages are referred to as "ip (interpretive program) messages." user-defined settings will impact the generation of flags and judgement of sample analysis.The initial hgb and mchc values were low.The user's anemia flag and hypochromia flag were disabled at the time of the event.The sysmex xt-2000i ifu, chapter 16 - appendix , section 16.1 - rbc/ret ip messages, discusses the default setting for anemia, which is hgb <10.0 g/dl and hypochromia which is mchc <29.0 g/dl.Had the user set the anemia and hypochromia flags to the default setting, the analyzer would have alerted the operator with a positive judgement.Due to qc generating out of range, the device was taken out of use on (b)(6) 2019 until further investigation could be performed.A sysmex service engineer (se) arrived on 11/11/2019.The se discovered the pressure and vacuum were out of specification.Multiple parts were replaced, cleaning and adjustments were made to resolve the issue.No one part replacement resolved the issue.Calibration was performed and analysis of quality control generated within specification, the device was operational and placed back in service.Whether the servicing performed was related to the event, could not be confirmed.No systemic product deficiency was identified.Root cause could not be determined.A sample aspiration issue could not be ruled out.

Event Description

The patient sample was analyzed and a critical low hemoglobin (hgb) result was generated.The sample was repeated with a similar result.Due to the low hgb result, the physician administered two units of packed red blood cells.The same sample was repeated 12 hours later and a normal hgb result was generated.Two more samples were collected from the patient post blood transfusion and normal hgb results were generated on both samples.There was no patient harm reported based on the administered blood transfusion.

• Brand Name: SYSMEX XT-2000I
• Type of Device: SYSMEX XT-2000I AUTOMATED HEMATOLOGY ANALYZE
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, 675-0 011; JA 675-0011
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, 675-0 011; JA 675-0011
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439678
• MDR Report Key: 9331064
• MDR Text Key: 175182361
• Report Number: 1000515253-2019-00019
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 04987562129164
• UDI-Public: (01)04987562129164
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K021241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2019

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
• Device Operator: Health Professional
• Device Model Number: XT-2000I
• Device Catalogue Number: 01325318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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: 46 YR