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 01/19/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable elecsys ft4 iii assay results for 3 patient samples on two cobas e 801 modules and a cobas e 411 immunoassay analyzer compared to an abbott architect analyzer.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results and medwatch with patient identifier (b)(6) for information on the tsh ver.2 results.The initial results were reported outside of the laboratory.The doctor questioned the results and the samples were sent out for investigational testing.The customer's e801 analyzer serial number was requested but not provided.The customer's ft4 iii reagent lot and expiration date were requested but not provided.The investigational e801 analyzer serial number is (b)(4).The investigational e801 reagent lot is 630888.The investigational e411 analyzer serial number is (b)(4).The investigational e411 reagent lot is 623234 and the expiration date is 30-apr-2023.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

The patient samples were not available for further investigation.It was determined that the result differences generated between the different methods are consistent with methodological differences.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 16405819
• MDR Text Key: 310125304
• Report Number: 1823260-2023-00521
• 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: 05/05/2023

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 Expiration Date: 05/31/2023
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 630888, 623234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 05/05/2023
• 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