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 12/15/2021

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on a cobas e 411 immunoassay analyzer.The clinical interpretation of the e411 result did not agree with the clinical interpretation of a result from a competitor system.No incorrect results were reported outside of the laboratory.The sample resulted in a ft4 value of 26.71 pmol/l (reference range = 12.00 - 22.00 pmol/l) accompanied by a data flag when tested on the e411 analyzer.The sample resulted in a ft4 value of 22.90 pmol/l (reference range = 8 - 24 pmol/l) when tested on a vidas analyzer.The serial number of the e411 analyzer was (b)(4).

Manufacturer Narrative

Calibration and qc were acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.From the information provided, a general reagent issue most likely can be excluded.Assay from different manufacturers can generate different results as they use different antibodies, have different setups, and have differences in the standardization methodologies.

• 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: 13117472
• MDR Text Key: 287586677
• Report Number: 1823260-2021-03928
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

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 Expiration Date: 05/31/2022
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 54716801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/31/2022
• 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