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

Model Number FT4 G3

Device Problem High Test Results (2457)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi): (b)(4).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on two cobas 8000 e 801 module analyzers.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2021, resulting with a ft4 value of 1.81 ng/dl (reference range = 0.90 - 1.70 ng/dl).This initial value was reported outside of the laboratory to a physician.The sample was repeated on a centaur analyzer, resulting with a ft4 value of 1.36 ng/dl (reference range = 0.83 - 1.71 ng/dl).The sample was also provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2020, resulting with a ft4 value of 1.75 ng/dl.The serial number of the customer's e 801 analyzer is (b)(4).The ft4 reagent lot number and expiration date used on this analyzer was requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 460793, with an expiration date of (b)(6) 2021 was used on this analyzer.

Manufacturer Narrative

Further investigations of the patient sample determined that it does not contain an interfering factor to a component of the assay.The differences in values measured with the different methods relate to differences in the setups of the assays, the antibodies, and differences in the standardization materials and procedures used.The investigation could not identify a product problem.

• 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: 11354332
• MDR Text Key: 246841199
• Report Number: 1823260-2021-00521
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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: 07976887190
• Device Lot Number: ASKU, 460793
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THYRADIN
• Patient Age: 46 YR