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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Date 02/03/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys ft4 iii assay results for one patient tested on two cobas 8000 e 801 modules.The customer performed testing with the patient's sample on an e 801 module and an abbott architect.The patient's ft4 results were reported outside the laboratory.The patient's physician questioned the results and requested further testing.On (b)(6) 2022, the customer provided the patient's sample for an investigation and the sample was tested on an e 801 module and a siemens centaur analyzer.The customer's e 801 module serial number was requested but not provided.The customer's ft4 reagent lot number and expiration date were requested but not provided.The investigation's e 801 module serial number was (b)(4).The investigation's ft4 reagent lot number was 572941 with an expiration date of 30-sep-2022.

Manufacturer Narrative

The customer's calibration and qc results, sample pre-analytic details, and system alarm trace were requested but not provided.The observed differences in ft4 values generated with the elecsys assay and the abbott assay are consistent with differences in the overall setups of the assays, the antibodies used, differences in reference materials, and the differences in the standardization methodology used.The customer's elecsys ft4 results were confirmed by the investigation's siemens centaur results.From the provided information, a general reagent issue could be excluded.Product labeling states, "for diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings." the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT4 III ASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13618618
• MDR Text Key: 292811386
• Report Number: 1823260-2022-00532
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• 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: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• 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