MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number FT3 G3

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys ft3 iii results for one patient tested on a cobas 8000 e 801 module.The e 801 module serial number was requested but was not provided.The customer reported the results to the patient's physician, and the physician asked for a re-measurement of the sample.The customer performed additional testing on an abbott architect.Also, the sample was submitted for an investigation and was tested on a cobas 8000 e 801 module and a cobas e 411 immunoassay analyzer.Refer to the attachment on the medwatch for all patient data.

Manufacturer Narrative

The customer's calibration, qc, and sample pre-analytic data were requested but not provided.The patient's sample was provided for an investigation.The investigation confirmed the customer's thyroid results.Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed, streptavidin.This interference is covered in 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.Updated medwatch field: d4.

• Brand Name: ELECSYS FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11095686
• MDR Text Key: 244805142
• Report Number: 1823260-2020-03448
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• PMA/PMN Number: K963127
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: FT3 G3
• Device Catalogue Number: 07027362190
• Device Lot Number: 476059
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR