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 10/15/2022

Event Type  malfunction  

Manufacturer Narrative

Na.

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 801 module.The e 801 results were reported outside of the laboratory to the doctor treating the patient.The patient has no history of signs of hyperthyroidism.This medwatch will apply to the ft3 assay.Please refer to the medwatch with patient identifier.Patient identifier:(b)(6) for information related to the ft4 assay.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer, serial number: (b)(4).The patient was administered neomercazole medication based on the e 801 results.The sample was repeated on an abbott alinity analyzer.

Manufacturer Narrative

A sample from the patient was provided for investigation and it was determined that the sample contains an interfering factor against the ruthenium label of the ft3 and ft4 assays.Per product labeling: "in rare cases, interference due to extremely high titers of antibodies toanalyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.".

• 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: 15715603
• MDR Text Key: 307586492
• Report Number: 1823260-2022-03464
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• 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: ASKU
• Device Lot Number: 593219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• 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
• Treatment: ALBUSOL (DAILY); ALDACTONE (BD); MGSO4 (BD); VITAMIN D
• Patient Age: 69 YR
• Patient Sex: Female