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

Model Number FT4 G2

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.Medwatch field unique device identifier (udi) (b)(4).Medwatch field - phone (b)(6).

Event Description

The initial reporter received questionable elecsys ft4 ii assay results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The patient's elecsys ft4 result was reported outside the laboratory.The patient's physician questioned the elecsys result and the customer performed repeat testing on an abbott analyzer.After the patient's sample was tested on the abbott analyzer, the repeat results were reported to the patient's physician.Refer to the attachment on the medwatch for all patient data.

Manufacturer Narrative

The customer sent one patient sample for further investigation.Ft4 results measured during the investigation were comparable to the result obtained by the customer.Upon further investigation of the patient sample, an interferent against a component of the reagent was not discovered.The difference between elecsys® ft4 iii and the respective assay from abbott is most likely based on methodological differences.Abbott's result is near the upper reference range, whereas elecsys is found above the reference range.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11680499
• MDR Text Key: 246011609
• Report Number: 1823260-2021-01164
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT4 G2
• Device Catalogue Number: 07027397190
• Device Lot Number: 483198
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR