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

Model Number FT4 G3

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

The country of origin is (b)(6).

Event Description

The initial reporter received questionable elecsys ft4 iii assay, elecsys tsh assay, and elecsys ft3 iii results from the cobas e 801 module.This mdr will cover the elecsys ft4 iii reagent.Refer to the mdr with patient identifier = (b)(6) for the elecsys ft3 iii assay reagent and the mdr with patient identifier = (b)(6) for the elecsys tsh assay reagent.See attachment (b)(6) for results.It was noted that additional tsh dilution test results were: x2 diluted: 1.810 uiu/ml, x5 diluted: 2.000 uiu/ml, x10 diluted: 2.110 uiu/ml.The questionable results were reported outside the laboratory.

Manufacturer Narrative

A sample was provided for investigation the observed differences in ft4 values generated with the roche assay and the different type of analyzers are 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.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: 9658879
• MDR Text Key: 195540475
• Report Number: 1823260-2020-00265
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 432844
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR