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 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for seven patient samples tested with the elecsys ft4 iii assay on two cobas 8000 e 801 module analyzers (serial numbers (b)(4).The values generated at the customer site were reported outside of the laboratory to a physician.The samples were tested for ft4 at the customer site on the two e 801 analyzers and repeated using the wako accuraseed assay.Samples from patient numbers (b)(6) were treated with polyethylene glycol (peg) and ft4 testing was repeated.

Manufacturer Narrative

The samples from patient numbers (b)(6) were repeated on an abbott architect analyzer and with the lc-ms/ms method.These samples were also provided for investigation, where they were tested on a third e 801 analyzer and a cobas e 411 immunoassay analyzer.When tested on the abbott architect, the sample from patient (b)(6) resulted with a ft4 value of 0.77 ng/dl (reference range = 0.70 - 1.48).When tested using the lc-ms/ms method, the ft4 value was 1.51 ng/dl.The sample was tested twice on the e801 analyzer used for investigation, resulting with ft4 values of 0.829 ng/dl and 0.901 ng/dl.When tested on the e 411 analyzer used for investigation, the ft4 value was 0.847.This sample resulted with an anti-tg value of < 28.0 iu/ml and an anti-tpo value of < 16.0 iu/ml.When tested on the abbott architect, the sample from patient (b)(6) resulted with a ft4 value of 0.75 ng/dl (reference range = 0.70 - 1.48).When tested using the lc-ms/ms method, the ft4 value was 1.50 ng/dl.The sample was tested twice on the e801 analyzer used for investigation, resulting with ft4 values of 0.862 ng/dl and 0.906 ng/dl.When tested on the e 411 analyzer used for investigation, the ft4 value was 0.949.This sample resulted with an anti-tg value of < 28.0 iu/ml and an anti-tpo value of < 16.0 iu/ml.The serial number of the e 801 analyzer used for investigation is (b)(6).Two ft4 reagent lot numbers were used on this analyzer; lot 460793 with expiration date of february 2021 and lot 432844 with expiration date of february 2021.It is not known which lot was used for each measurement.The serial number of the e 411 analyzer used for investigation is (b)(6).Ft4 reagent lot 443835, with an expiration date of november 2021 was used on this analyzer.

Manufacturer Narrative

The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.

• 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: 10142793
• MDR Text Key: 202814182
• Report Number: 1823260-2020-01425
• 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,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• 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: 432844
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR