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

Model Number XN-10

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 12/22/2018

Event Type  Injury  

Manufacturer Narrative

Improper lifting technique by the user while changing the reagent caused this event.Good safety practices would indicate using safety measures recommended by the occupational safety and health administration (osha) and niosh (national institute of occupational health and safety) to lift heavier objects such as the reagent cube.For example, lifting aids such as a dolly or a cart for transport or lifting with assistance of another employee would aid the user in transporting the reagent cube and avoiding potential injury.Teaching employees ergonomic lifting techniques can also prevent injuries.The employer is responsible for assessing risk and providing adequate training and engineering controls for all reagents and other materials used in a laboratory.Cellpack® dst packaging encourages proper lifting by providing handles on two sides of the box.The reagent is also available in a smaller size as two 4l containers to reduce the package weight.The user switched over to the smaller size containers for both reagents to accommodate their staff.

Event Description

The user reported a knee injury while replacing the cellpack dst 20l reagent.The injury occurred when the user was loading the reagent onto the pull-out drawer of the xn-9100 line.The user stated there wasn't enough room to place the box near the drawer and then lift the container into the drawer.The user reached and twisted to lift the reagent into the drawer.This resulted in an injury to her knee.The user did not seek immediate medical treatment for the injured knee and continued working the scheduled shift.The user continued working all scheduled shifts and did not see a physician until (b)(6) 2018.The orthopedic physician scheduled an mri for the involved user on (b)(6) 2019.Based on the results of the mri, that revealed torn cartilage in her knee, surgery was performed in mid-february.It is unknown if the user had previous known knee issues or what type of surgery was performed.The user returned to work on (b)(6) 2019.

• Brand Name: XN-10
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, 675-0 019; JA 675-0019
• Manufacturer (Section G): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, 675-0 019; JA 675-0019
• Manufacturer Contact: jasna frontz ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439753
• MDR Report Key: 8601090
• MDR Text Key: 144743144
• Report Number: 1000515253-2019-00011
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 4987562424214
• UDI-Public: (01)4987562424214
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• 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
• Date Manufacturer Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2018
• 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