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

Model Number FT4 G3

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys tsh, elecsys ft3 iii, elecsys ft4 iii, and elecsys ft4 iv on a cobas e411 disk and a cobas e411 rack.No questionable results were reported outside of the laboratory.This medwatch will apply to the ft4 iii assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the tsh assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft3 iii assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft4 iv assay.Refer to the attachment for all patient data.The values highlighted in yellow are questionable.The sample was initially tested on the customer's e411 disk analyzer on (b)(6) 2023.The sample was repeated using the abbott architect method.The customer performed additional dilution study measurements with the tsh assay on their e411 disk analyzer, including 1:5, 1:10, 1:20, 1:50, and 1:100 dilutions.The customer also treated the sample with a 25 % polyethylene glycol solution and repeated tsh, ft3 iii, and ft4 iii measurements on the e411 disk analyzer.The sample was then provided for investigation, where it was tested using an e411 rack analyzer on (b)(6) 2023.

Manufacturer Narrative

The serial number of the customer's e411 disk analyzer is (b)(6).The ft4 iii reagent lot number and expiration date used on this analyzer were requested, but not provided.The serial number of the e411 rack analyzer used for investigation is (b)(6).The ft4 iii reagent lot number used on this analyzer was 675279, with an expiration date of 30-nov-2023.

Manufacturer Narrative

The difference in values for the different methods relates to differences in the setups of the assays, the antibodies used, and differences in the standardization materials and procedures used.An interfering factor can most likely be excluded.The investigation could not identify a product problem.

• Brand Name: ELECSYS FT4 III
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17383597
• MDR Text Key: 320610610
• Report Number: 1823260-2023-02426
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

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 Model Number: FT4 G3
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU, 675279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female