MAUDE Adverse Event Report: BECKMAN COULTER ACCESS FREE T4; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 33880

Device Problem High Test Results (2457)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 07/11/2014

Event Type  Injury  

Event Description

The customer reported obtaining elevated free t4 (access frt4) results, for one (1) patient over multiple days, involving the unicel dxi access immunoassay system.This report references the event which occurred on (b)(6) 2014; please refer to medwatch report number 8020879-2014-00012 for the report of the event which occurred on (b)(6) 2014.The elevated frt4 result was reported out of the laboratory and the physician performed a thyroidectomy on the patient on (b)(6) 2014 based on the frt4 result and because the patient had trouble swallowing.The access frt4 reagent was used in conjunction with the unicel dxi access immunoassay system serial number (b)(4) for this event.

Manufacturer Narrative

The customer provided two (2) patient samples to beckman coulter for investigation.Beckman coulter tested the samples neat (undiluted) following centrifugation for the frt4 assay and obtained elevated frt4 results which matched the customer's results.Beckman coulter also performed an interference testing using a mix of different blockers and the testing did not allow to detect interference since none of the blockers used were able to modify the signal.Beckman coulter then performed an anti-streptavidin antibodies/biotin depletion testing.The depletion testing did not allow to detect an interference related either to strepravidin or to biotin within the provided patient samples.Beckman coulter's investigation could not demonstrate any interference and the cause of the discordance could not be determined.All related medwatch reports associated with this event: 8020879-2014-00012; 8020879-2014-00013.

• Brand Name: ACCESS FREE T4
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER IRELAND; mervue business park; mervue, galway, ; EI
• Manufacturer Contact: dung nguyen ; 250 s. kraemer boulevard; brea, CA 92821 ; 7149614941
• MDR Report Key: 4215987
• MDR Text Key: 4977201
• Report Number: 8020879-2014-00013
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K982250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 33880
• Device Lot Number: 470064
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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