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

Model Number FT4 G2

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of a questionable elecsys ft4 ii assay result from 1 patient tested on a cobas 8000 e 801 module compared to the result from an abbott architect.The customer suspects an interference.The customer received the patient sample from another laboratory to verify the ft4 results from the other laboratory's cobas 8000 e 602 module.The results from the other laboratory were requested but have not been provided.The ft4 ii result from the customer's cobas e801 was 55.2 pmol/l.The ft4 result from an abbott architect was 25.5 pmol/l.The results in question were reported outside of the laboratory but no treatment was provided the cobas e801 serial number was (b)(4).

Manufacturer Narrative

The investigation determined the calibration signals and qc recovered as expected and within range.A general reagent issue can most likely be excluded.The customer did not return any materials for investigation.Without these materials, a specific root cause could not be determined.Different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.

Manufacturer Narrative

A patient sample was submitted for investigation.The customer's high result was reproduced.An interfering factor was not identified.A product problem was not found.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9118398
• MDR Text Key: 217983955
• Report Number: 1823260-2019-03438
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

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: 06/30/2020
• Device Model Number: FT4 G2
• Device Catalogue Number: 07976887190
• Device Lot Number: 413768
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 09/06/2019; 09/06/2019
• Supplement Dates FDA Received: 12/03/2019; 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1