MAUDE Adverse Event Report: SYSMEX CORPORATION XN-550; AUTOMATED HEMATOLOGY ANALYZER

Model Number XN-550

Device Problem Application Program Problem (2880)

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

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

It was determined that the lack of additional mixing after clearing the error is abnormal operation that occurs only with samples collected in sarstedt brand tubes or bd microtainer "map" tubes.The root cause is a software bug that will be addressed in a future software update.

Event Description

A host communication error occurred while a patient sample was being analyzed in sampler mode, which caused the analyzer to stop.Analysis could not continue processing until the operator acknowledged the error approximately 16 minutes after the error stopped analyzer operation.During this time sedimentation of the blood sample occurred.After accepting the error and pressing start, the sample continued processing the sample without additional mixing.This led to incorrect measurement results due to sedimentation, which were reported to the clinician.The physician questioned the results and the incorrect results were not used for decision making or treatment.

• Brand Name: XN-550
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa-city, hyogo 675-0 011; JA 675-0011
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa-city, hyogo 675-0 011; JA 675-0011
• Manufacturer Contact: peter shearstone ; 577 aptakisic rd; lincolnshire, IL 60069
• MDR Report Key: 6426817
• MDR Text Key: 70631486
• Report Number: 1000515253-2017-00007
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Model Number: XN-550
• Device Catalogue Number: BD634545
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2016
• 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