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

Model Number FT4 G3

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for two samples from the same patient tested with elecsys ft3 iii and the elecsys ft4 iii assay on a cobas 8000 e 801 module analyzer.The second sample had discrepant ft3 and ft4 results when tested on a second e 801 analyzer used for investigation.The second sample also had a discrepant ft3 result when tested on an e411 analyzer used for investigation.No 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)(6) for information related to the ft4 assay.The first patient sample was initially tested on the customer's e 801 analyzer on (b)(6) 2021.The second sample was initially tested on the customer's e 801 analyzer on (b)(6) 2021.Both samples were repeated on an abbott architect analyzer.The second sample was repeated on a siemens centaur analyzer.The second sample was tested on an e 801 analyzer and an e411 analyzer used for investigation on (b)(6) 2020.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 was requested, but 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 february 2021 was used on this analyzer.

Manufacturer Narrative

Further investigations of one sample from the patient determined it contains an interfering factor against the streptavidin component of the ft3 and ft4 assays.The sample may also contain an interfering factor against the ruthenium component of these assays, but this could not be confirmed with certainty.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.".

• 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: 11300203
• MDR Text Key: 250323929
• Report Number: 1823260-2021-00383
• 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: 04/22/2021

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: 01/15/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THYRADIN
• Patient Age: 70 YR