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 Consequences Or Impact To Patient (2199)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The e801 module serial number used at the investigation site was (b)(4).The ft4 iii reagent lot number used at the investigation site was 380330 with an expiration date of dec-2019.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft3 iii (ft3 iii) on a cobas e801 module compared to the wako accuraseed method.The results from the e801 module were reported outside of the laboratory.The patient sample was submitted for investigation where discrepant results were identified for ft3 iii, elecsys tsh (tsh), elecsys ft4 iii (ft4 iii) and elecsys ft4 ii (ft4 ii) between the customer's e801 module, the abbott architect method, the accuraseed method and an e801 module used at the investigation site.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results, medwatch with patient identifier (b)(6) for information on the tsh results and medwatch with patient identifier (b)(6) for information on the ft4 ii results.The customer's e801 module serial number was (b)(4).

Manufacturer Narrative

The patient sample was submitted for investigation.No interfering factor was identified in the sample.The investigation did not identify a product problem.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used.

• 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: 9083354
• MDR Text Key: 216347326
• Report Number: 1823260-2019-03370
• 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: 02/11/2020

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: 08/30/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR