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 12/08/2022

Event Type  malfunction  

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.

Event Description

The initial reporter stated they received discrepant thyroid test results for three patient samples tested on two cobas 8000 e 801 modules and a cobas e 411 immunoassay analyzer.Results for the following assays were affected: the elecsys tsh assay and the elecsys ft4 iii assay.The specific date of the event is not known.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay.Refer to the attachment for all patient data.All highlighted values are questionable.The samples were initially tested at the customer site on their e 801 analyzer.The samples were then provided for investigation, where they were tested on a second e 801 analyzer and an e411 analyzer on (b)(6) 2022.The samples were also repeated on an abbott architect analyzer on (b)(6) 2022.The serial number of the customer's e 801 analyzer was requested, but not provided.The ft4 reagent lot number and expiration date used on this analyzer were requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 630888, with an expiration date of 31-may-2023 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Ft4 reagent lot number 623234, with an expiration date of 30-apr-2023.

• Brand Name: ELECSYS FT4 III
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 16032982
• MDR Text Key: 308383670
• Report Number: 1823260-2022-04148
• 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
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• 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, 630888, 623234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• 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