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

Model Number UNICEL DXC 800 PRO, PACKAGED

Device Problem Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

No parts were replaced.There is insufficient evidence of a system or reagent malfunction.The issue occurred due to use error.No further issues were reported from the field service engineer.Beckman coulter internal identifier is (b)(4).No patient demographic information was provided.

Event Description

The field service engineer sprained his back while kneeling, twisting and reaching into the instrument's hydro-pneumatics area to complete routine maintenance on the unicel dxc 800 pro synchron system.

• Brand Name: UNICEL DXC 800 PRO 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: david davis ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 8819806
• MDR Text Key: 152024841
• Report Number: 2050012-2019-01091
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 15099590280994
• UDI-Public: (01)15099590280994(11)NO-DATA
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNICEL DXC 800 PRO, PACKAGED
• Device Catalogue Number: A10407
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/20/2018
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2005
• 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