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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

The customer's calibration and qc results, sample pre-analytic details, and system alarm trace were requested but not provided.From the provided information, a general reagent issue could be excluded.The observed differences in ft4 values generated with the roche assay and siemens centaur assay are most likely caused by differences in the overall setups of the assays, the antibodies used, differences in reference materials, and the differences in the standardization methodology used.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable elecsys ft4 iii assay for one patient tested on two cobas 8000 e 801 modules.The patient's initial ft4 result on the customer's e 801 module was reported outside the laboratory.The patient's physician questioned the reported result and requested further testing.The customer sent the patient's sample for an investigation and the sample was tested on an e 801 module and a siemens centaur analyzer.Refer to the attachment on the medwatch for all patient data.The e 801 module serial number used at the customer's site was requested but not provided.The e 801 module serial number used at the investigation's site was (b)(4).The customer's ft4 reagent lot number and expiration date were requested but not provided.The investigation's ft4 reagent lot number was 541093 with an expiration date of 31-may-2022.

• 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: 12984430
• MDR Text Key: 289967079
• Report Number: 1823260-2021-03669
• 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: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• 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: 541093, ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• 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