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

Model Number FT4 G3

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys ft4 iii, elecsys ft3 iii (ft3 iii) and elecsys ft3 iii ver.2 assay results for 2 samples from the same patient tested on the customer's cobas 6000 e 601 module with serial number 15v0-20 and the investigation site's cobas e 602 module with serial number (b)(4).This medwatch is for the elecsys ft4 iii assay.Refer to medwatch with patient identifier (b)(6) for the ft3 iii assay and medwatch with patient identifier (b)(6) for the ft3 iii v2 assay.It is not known if the results were reported to the patient or medical personnel.The reporter stated since they switched from the "architect" to the e 601 in (b)(6) 2022, the trend of the patient's three measurement items has changed.One of the patient samples was rerun at a customer affiliated laboratory that uses an abbott architect.A discrepancy was noted prompting reruns of the patient samples at the investigation site laboratory.Refer to the attachment in the medwatch for the highlighted questionable results.The ft4 iii reagent lot number used at the investigation site's e 602 is 593219 with an expiration date of 31-dec-2022.

Manufacturer Narrative

The patient samples were requested for investigation.

Manufacturer Narrative

The two patient samples were received for investigation.Sample20220912 was insufficient for investigation.An interfering factor against sulfo-ruthenium (ru) label was identified in sample 20220815.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.

• Brand Name: ELECSYS FT4 III
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15624639
• MDR Text Key: 307111610
• Report Number: 1823260-2022-03225
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

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: 04/30/2023
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 62323400, 593219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female