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

Model Number FT3 G3

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer provided two samples for an investigation.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys ft3 iii results for two patients tested on a cobas 8000 e 801 module serial number (b)(4).The customer reported the ft3 results to a physician who asked for re-measurement of the samples.The samples were sent for an investigation and were tested on a cobas 8000 e 801 module, cobas 8000 e 602 module, cobas e 411 immunoassay analyzer, and a siemens centaur 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.Upon further investigation of patient 1's and patient 2's samples, an interferent against a component of the reagent was not confirmed.Per product labeling, "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.The cause of the event could not be determined.

• 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: 11215847
• MDR Text Key: 250758920
• Report Number: 1823260-2021-00243
• 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: 01/22/2021
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1