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

Model Number FT4 G3

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The sample was requested for investigation.The sample was submitted for investigation where interference testing was performed.All results were found to be within reference range.An interfering factor was not identified.

Event Description

The initial reporter complained of low results not corresponding to the clinical picture for 1 patient sample tested for elecsys ft4 iii (ft4 iii) on a cobas e801 module.The ft4 iii result was 0.73 ng/dl.This result was reported outside of the laboratory and was questioned by the physician since the result did not match the clinical picture of the patient.The customer tested the sample on different modules in the laboratory and continued to receive low ft4 results.The specific results were not provided.The e801 module serial number was (b)(4).

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 10339313
• MDR Text Key: 200829535
• Report Number: 1823260-2020-01829
• 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: 09/09/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR