MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 III ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 07976887190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).

Event Description

The customer complained of questionable high elecsys ft4 iii assay results for 1 patient tested on a cobas 8000 e 801 module compared to an abbott architect and a siemens system.The customer stated that the patient is healthy and therefore the results are not matching the patient's clinical picture.The customer suspects there is an interference.For sample 1 on cobas e801 serial number (b)(4) the ft4 iii result was 94.8 pmol/l for sample 2 on cobas e801 serial number (b)(4) the ft4 iii result was >100 pmol/l.The result from an abbott architect was 12.8 pmol/l.The customer stated that they had a similar result from the siemens system.The customer also mentioned that a third sample, sample 3, showed similar results.Sample 1, 2, and 3 were all separate samples.The questionable results were reported outside of the laboratory, but the clinician questioned the results as the patient was considered "clinically fine." there was no allegation of an adverse event.

Manufacturer Narrative

The very high ft4 values could not be reproduced.Further investigation of the samples identified an interfering factor for ft4.This interference is documented in product labeling.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8184174
• MDR Text Key: 131229372
• Report Number: 1823260-2018-05041
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 07976887190
• Device Lot Number: 35675600
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1