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 Consequences Or Impact To Patient (2199)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of questionable thyroid results for 1 patient tested on a cobas 8000 e 801 module.From the data provided, the investigation site's elecsys ft4 ii assay and elecsys ft4 iii assay results tested on a cobas e801 and compared to a centaur were discrepant.This medwatch will cover ft4 ii.Please refer to the patient identifier (b)(6) for information on ft4 iii.It was unknown if the results in question were reported outside of the laboratory.The cobas e801 serial number used at the customer's site was requested but not provided.The ft4 iii reagent lot used at the customer site was requested but was not provided.The investigation site's cobas e801 serial number was (b)(4).

Manufacturer Narrative

The investigation did not identify a product problem.All results were comparable to the competitor measurements for the medical interpretation based on the assay¿s reference range.

• 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: 9279909
• MDR Text Key: 219326056
• Report Number: 1823260-2019-03972
• 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: 12/16/2019

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 Expiration Date: 06/30/2020
• Device Model Number: FT4 G2
• Device Catalogue Number: 07027397190
• Device Lot Number: 396434
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1