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

Model Number FT4 G3

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6) the alleged samples were requested to be returned for investigation.Product labeling states: "the following special thyroid drugs were tested.No interference with the assay was found", "amiodarone tested with a concentration of 200 g/ml".The investigation is ongoing.

Event Description

The initial reporter alleged questionable elecsys ft4 iii assay results for an unspecified number of patient samples on a cobas 6000 e 601 module, serial number (b)(4).The initial reporter suspected an interference and stated that elderly patients who receive corderone (amiodaron) regularly will measure false high results.Numerical values were not provided.

Manufacturer Narrative

The sample was not returned for investigation.A detailed investigation is not possible.Neither detailed sample result information (copy of measured values) nor other information on patient history was provided.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: 11097571
• MDR Text Key: 244805136
• Report Number: 1823260-2020-03454
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORDERONE (AMIODARON) INJECTIONS OF 100-200 MG