MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number A64871

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

A beckman coulter field service engineer (fse) was sent to the customer site.The fse replaced the sample mixer wash assembly to resolve the issue.(b)(4).

Event Description

The customer reported the unicel dxc 660i synchron access clinical system generated suppressed tg results for three patient samples.The customer repeated the samples on the same dxc instrument and obtained tg results considered correct.The customer noted the results were not reported outside of the lab and there was no impact to patient treatment.

• Brand Name: UNICEL DXC 660I SYNCHRON ACCESS CLINICAL 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: 5689221
• MDR Text Key: 46224755
• Report Number: 2050012-2016-00189
• Device Sequence Number: 0
• Product Code: JZO
• Reporter Country Code: US
• PMA/PMN Number: K060256
• 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: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A64871
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2013
• 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