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

Model Number FT4 G3

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on two cobas 8000 e 801 module analyzers.The initial values were reported outside of the laboratory to a physician.When tested on the customer's e 801 analyzer on (b)(6) 2020, the sample resulted with a ft4 value of 1.77 ng/dl (reference range = 0.90 - 1.70 ng/dl).The sample was repeated on an abbott architect analyzer, resulting with a ft4 value of 1.33 ng/dl (reference range = 0.70 - 1.48 ng/dl).The sample was also provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2020, resulting with a ft4 value of 1.74 ng/dl.The serial number of the customer's e 801 analyzer is (b)(4).The ft4 reagent lot number and expiration date used on this analyzer were not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 460793, with an expiration date of november 2020 was used on this analyzer.

Manufacturer Narrative

The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.

• 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: 10969743
• MDR Text Key: 220701933
• Report Number: 1823260-2020-03144
• 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: 02/02/2021

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, 460793
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1