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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi): (b)(4).The sample was requested for further investigation.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft4 iii (ft4 iii) and elecsys ft3 iii (ft3 iii) on a cobas e801 module compared to an accuraseed analyzer.The roche results were reported outside of the laboratory where the physician requested additional testing.The sample was submitted for investigation where discrepant results were identified between the customer¿s e801 module, the accuraseed analyzer, an e801 module used at the investigation site and an abbott architect analyzer.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results.Refer to attached data for the patient results.The customer¿s e801 module serial number was (b)(4).The e801 module used at the investigation site was (b)(4).The ft4 iii reagent lot number used at the investigation site was 483198 with an expiration date of jun-2021.

Manufacturer Narrative

The sample was submitted for investigation and tested on an e801 module.The customer's high results were reproduced.Further investigation of the sample confirmed the presence of an interfering factor against the chemical ruthenium label causing falsely increased values with the ft4 iii and ft3 iii assays.This specific interference is addressed 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." the investigation did not identify a product problem.

• 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: 11613334
• MDR Text Key: 249161189
• Report Number: 1823260-2021-01007
• 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: 06/07/2021

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: 03/12/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR