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 09/24/2022

Event Type  malfunction  

Manufacturer Narrative

The customer treated the sample with polyethylene glycol (peg) to test for interference.Calibration and qc at the investigation site were acceptable.From the information provided, a general reagent issue can be excluded.Based on the data provided, an interfering factor can be excluded.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and the standardization methodology used.The investigation did not identify a product problem.

Event Description

The initial reporter questioned thyroid results for 1 patient sample tested on a cobas e801 module compared to the accuraseed method.The sample was submitted for investigation where discrepant results were identified for elecsys ft4 iii (ft4 iii) between the customer¿s e801 module, the wako accuraseed method, an e801 module used at the investigation site, and the abbott architect method.The result from the customer¿s e801 module was 1.76 ng/dl.The result from the accuraseed method was 1.70 ng/dl.The result from the e801 module used at the investigation site was 1.66 ng/dl.The result from the architect method was 1.45 ng/dl.No questionable results were reported outside of the laboratory.The customer¿s e801 module serial number was (b)(4).The e801 module used at the investigation site was 14d9-06.The ft4 iii reagent lot number used at the investigation site was 630888 with an expiration date of 31-may-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: 15668546
• MDR Text Key: 307156427
• Report Number: 1823260-2022-03348
• 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: 10/25/2022

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: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/25/2022
• 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
• Patient Age: 23 YR
• Patient Sex: Male