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 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii and the elecsys ft4 iii assay on two cobas 8000 e 801 module analyzers.The results generated at the customer site were reported outside of the laboratory to a physician.This medwatch will apply to the ft4 assay.Patient identifier (b)(6) for information related to the ft3 assay.Refer to the attachment for all patient data.The sample was collected from the patient on (b)(6) 2019 and initially tested on the customer's e 801 analyzer on (b)(6) 2020.The customer also repeated the sample using the wako accuraseed method.The sample was also repeated on an abbott architect analyzer and with an lc-ms/ms method.The sample was provided for investigation, where it was tested on a second e 801 analyzer on (b)(6)2020.The serial number of the customer's e 801 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 460793, with an expiration date of february 2021 was used on this analyzer.Ft4 reagent lot number 432844, with an expiration date of september 2020 was also used on this analyzer.

Manufacturer Narrative

The observed differences in ft4 values generated with the roche assay and wako and abbott assays are most likely caused by differences in the overall setups of the assays, the antibodies used, differences in reference materials, and the differences in 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: 10206662
• MDR Text Key: 200636979
• Report Number: 1823260-2020-01567
• 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: 08/10/2020

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: 07976836190
• Device Lot Number: 460793
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1