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

Catalog Number A11812

Device Problem Low Test Results (2458)

Patient Problem Hyperglycemia (1905)

Event Date 10/01/2014

Event Type  Injury  

Event Description

The customer reported obtaining an erroneously low glum (glucose) result for one (1) patient, involving the unicel dxc 800 pro synchron system.The result was questioned when there was a discrepancy between the unicel dxc 800 pro synchron system result and an alternate methodology.The customer repeated the sample on another unicel dxc system and obtained a higher glum result.The erroneously low glum result was reported outside the laboratory.The patient received an iv (intravenous) due to the erroneously low glum result.Quality control was within laboratory's established ranges on the day of the event.

Manufacturer Narrative

A field service engineer (fse) was dispatched and evaluated the instrument.The fse found the accusense glucose oxygen sensor electrode damaged caused by customer use error.The customer had incorrectly installed the accusense glucose oxygen sensor electrode during maintenance.The fse replaced the accusense glucose oxygen sensor electrode to resolve the issue.

• 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 800
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821 800
• Manufacturer Contact: dung nguyen ; 250 s. kraemer blvd; brea, CA 92821-8000 ; 7149614941
• MDR Report Key: 4200441
• MDR Text Key: 4961574
• Report Number: 2050012-2014-00478
• Device Sequence Number: 1
• Product Code: CGA
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2014

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 Catalogue Number: A11812
• Other Device ID Number: SOFTWARE VERSION 5.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2005
• 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