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 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft3 iii (ft3 iii) and elecsys ft4 iii (ft4 iii) on a cobas e801 module compared to the accuraseed method.The sample was submitted for investigation where discrepant ft3 iii and ft4 iii results were identified between the customer's 801 module, an e801 module used at the investigation site and the architect method.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results.The initial results were reported outside of the laboratory.The customer's e801 module serial number is (b)(4).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.

Manufacturer Narrative

The investigation determined that the differences of the ft4 values generated with different analyzers are caused by differences in the setup of the assays, the antibodies used and differences of the standardization materials and procedures used.No product problem could be found.

• 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: 9530298
• MDR Text Key: 219577761
• Report Number: 1823260-2019-04574
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 07976836190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1