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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Udi number = (b)(4).

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 a cobas 8000 e 602 module.The initial sample values were reported outside of the laboratory.The results from the e 602 did not correlate with the patient's physical symptoms.This medwatch will apply to the ft4 assay.Patient identifier (b)(6) for information related to the ft3 assay.The sample was tested twice on the e 602 analyzer, resulting with ft3 values of 6.290 pg/ml and 6.110 pg/ml (reference range = 2.0 - 4.4 pg/ml).The sample was repeated on an abbott architect analyzer on (b)(6) 2021, resulting with a ft3 value of 1.44 pg/ml (reference range = 1.88 - 3.18 pg/ml).The sample was tested twice on the e 602 analyzer, resulting with ft4 values of 2.980 ng/dl and 2.770 ng/dl (reference range = 0.93 - 1.71 ng/dl).The sample was repeated on an abbott architect analyzer on (b)(6) 2021, resulting with a ft4 value of 0.69 ng/dl (reference range = 0.70 - 1.48 ng/dl).The serial number of the customer's e 602 analyzer is (b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation.The results obtained by the customer could not be reproduced.The measured results were comparable to the results measured with the abbott assay.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 11614651
• MDR Text Key: 246277363
• Report Number: 1823260-2021-01017
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• 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: 47808501
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DILANTIN; VALIUM
• Patient Age: 57 YR