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

Model Number FT4 G3

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received discrepant results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay on a cobas 8000 e 801 module.The sample also had a discrepant value when tested with the elecsys ft4 ii assay on a second e 801 analyzer that was used for investigation.The results measured on the reporter's analyzer were reported outside of the laboratory.This medwatch will apply to the ft4iii assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft4ii assay.The sample was tested at the customer site on (b)(6) 2019.The sample was repeated on an abbott architect analyzer.The sample was also provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2019.No adverse events were alleged to have occurred with the patient.The serial number of the reporter's e 801 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4iii reagent lot number 380330, with an expiration date of december 2019 was used on this analyzer.

Manufacturer Narrative

The customer sent the patient sample to the manufacturer for investigation.The customer's ft3, ft4 ii, and tsh results were reproduced.The differences of the tsh and ft4 values, generated with the different types of analyzers, are caused by differences of the setups of the assays, the antibodies used and differences of the standardization materials and procedures 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: 8779939
• MDR Text Key: 150757741
• Report Number: 1823260-2019-02510
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• 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: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR