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

Model Number FT4 G3

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii and the elecsys ft4 iii assay on two cobas 8000 e 801 module analyzers.The values measured at the customer site were reported outside of the laboratory to a physician.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay.The sample was collected from the patient on (b)(6) 2020 and tested on the customer's e 801 analyzer on (b)(6) 2020.The sample was repeated at the customer site using the wako accuraseed method.The sample was repeated on an abbott architect analyzer.The sample was also provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2020.During investigations, the sample was treated with 25% polyethylene glycol (peg) and measured for ft3 and ft4.The e 801 analyzer used at the customer site is serial number (b)(4).The e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 432844, with an expiration date of (b)(6) 2020 was used on this analyzer.

Manufacturer Narrative

A sample from the patient was provided for investigation.During investigations, the results obtained by the customer could be reproduced.The investigation did not identify an interfering factor.The investigation could 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: 10133630
• MDR Text Key: 196166435
• Report Number: 1823260-2020-01385
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THYRADIN.
• Patient Age: 34 YR