MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXC 800 SYNCHRON SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number DXC 800 AR PACKAGED SYSTEM

Device Problem Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

A beckman coulter field service engineer (fse) was dispatched and evaluated the device.The fse noted the customer's water filter system was located behind the dxc 800 analyzer.The fse noted a short water line in the back of the dxc instrument.The fse added 10 feet of extra water line to the back of the dxc instrument.The fse did not find evidence of a system or reagent malfunction.Beckman coulter internal identifier is case (b)(4).Sex: female.Other patient demographic information was not provided.

Event Description

The customer reported that a laboratory technician was injured from tripping and falling over a water line, that was connected from the laboratory¿s water filter system to the back of the unicel dxc 800 synchron system.The technician injured her right elbow and wrist resulted in swelling and bruising.The technician sought medical attention in the emergency room (er).

• Brand Name: UNICEL DXC 800 SYNCHRON SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 9845791
• MDR Text Key: 188634632
• Report Number: 2050012-2020-00027
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 15099590369507
• UDI-Public: (01)15099590369507(11)180823
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DXC 800 AR PACKAGED SYSTEM
• Device Catalogue Number: A80377
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/05/2020
• Date Manufacturer Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other