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 Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The initial reporter stated they received discrepant results for four patient samples tested with thyroid assays on the cobas 8000 e 801 module and the following analyzers used for investigation: a second e 801 analyzer, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer.Affected tests include elecsys ft3 iii, the elecsys ft4 iii assay, and the elecsys tsh assay.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(4) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(4) for information related to the tsh assay.Refer to the attachment for all patient data.Values highlighted in yellow are discrepant.The samples were initially tested on the reporter's e 801 analyzer on (b)(6) 2019.The sample was repeated on a centaur analyzer.The sample was also provided for investigation where it was tested on the e 602 analyzer and e411 analyzer used for investigation on (b)(6) 2019.During investigations, the sample was tested on the second e 801 analyzer on (b)(6) 2019.The e 801 analyzer used by the reporter is serial number (b)(4).The e 602 analyzer used for investigation is serial number (b)(4).Ft4 reagent lot number 391521, with an expiration date of 29-feb-2020 was used on this analyzer.The e411 analyzer used for investigation is serial number (b)(4).Ft4 reagent lot number 391521, with an expiration date of 29-feb-2020 was used on this analyzer.The e 801 analyzer used for investigation is serial number (b)(4).Ft4 reagent lot number 380330, with an expiration date of 31-dec-2019 was used on this analyzer.

Manufacturer Narrative

Upon further investigation of sample ids 191004-758, 191005-1412, and 191008-610, the values generated at the customer site could be reproduced.It was determined these samples contained an interfering factor to the streptavidin component of the ft3 and ft4 assays.This limitation is covered in product labeling.Product labeling states: "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.".

• 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: 9280013
• MDR Text Key: 219596460
• Report Number: 1823260-2019-03973
• 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: 02/13/2020

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 Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1