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

Model Number FT4 G3

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter received questionable reproducible elecsys ft4 iii assay results for one patient from elecsys 2010 disk analyzer serial number (b)(4).The customer suspected interference as the results do not fit the clinical picture in a patient with multiple sclerosis under treatment with the immunoregulating drug coparaxon 40 (glatiramer).The ft4 results were 2.28 ng/dl and 2.26 ng/dl.Information was requested if any questionable result was reported outside of the laboratory, but it was not known.

Manufacturer Narrative

The investigation did not identify a product problem. the cause of the event could not be determined. .

• 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: 10900421
• MDR Text Key: 219176835
• Report Number: 1823260-2020-03008
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 47808501
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1