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 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.This event occurred in (b)(6).Unique identifier (udi) #: (b)(4).

Event Description

The initial reporter received questionable elecsys ft3 iii results for one patient with the cobas e 801 module serial number unknown.The customer reported the ft3 results to a physician who asked for a re-measurement of the samples.The samples were sent for an investigation and were tested on a cobas e801 module, cobas e 411 immunoassay analyzer, and a siemens centaur analyzer.The investigation site e801 module serial number was (b)(4).The e411 serial number was (b)(4).The ft3 reagent used at the investigation site was lot number 476059 with an expiration date of aug-2021.Refer to the attachment on the medwatch for all patient data.

Manufacturer Narrative

The calibration and qc data were requested but not provided.Further investigations were performed on the patient sample.An interfering factor has been confirmed within the sample, which affects elecsys ft3 iii on the different platforms to a different extent.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.A general product problem can be excluded.

• 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: 11373728
• MDR Text Key: 243231838
• Report Number: 1823260-2021-00558
• 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: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT3 G3
• Device Catalogue Number: 07027362190
• Device Lot Number: 476059
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1