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 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys ft4 iii assay results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The patient's initial ft4 result was reported outside the laboratory.The physician asked for a re-measurement of the patient's sample.The customer performed repeat testing on an accuraseed analyzer.The patient's sample was sent outside the laboratory for further testing on a cobas 8000 e 801 module and an abbott architect.

Manufacturer Narrative

The customer's calibration, qc, sample pre-analytical details, and system alarm trace were requested but not provided.The patient's sample was provided for an investigation.The investigation tested the patient's sample on a cobas 8000 e 801 module and the ft4 result was 1.80 ng/dl and the tsh result was 0.083 uiu/ml.The investigation reproduced the customer's ft4 and tsh result.The observed differences in ft4 values generated with the roche assay and the abbott 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.For the assay tsh, an interferent against a component of the reagent was confirmed, ruthenium label.This interference is covered in product labeling: per product labeling, "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.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.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12302494
• MDR Text Key: 266006274
• Report Number: 1823260-2021-02329
• 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
• Report Date: 09/28/2021

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
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1