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 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The event occurred in (b)(6).

Event Description

The initial reporter received questionable elecsys ft3 iii and elecsys ft4 ii assay results for one patient sample tested on a cobas 6000 e601 module with serial number (b)(4).The initial results were reported to the medical personnel and the patient.The patient's sample was rerun on a siemen's analyzer with an unknown method.This medwatch is for the ft4 assay.Refer to the medwatch with patient identifier (b)(6) for the ft3 assay.

Manufacturer Narrative

Updated medwatch field: b7 other relevant history.

Manufacturer Narrative

A sample from the patient was provided for investigation.The customer's high ft4 result from the analyzer could not be reproduced.An ft4 iii assay was performed and the result was found to be below the reference range and was comparable to the competitor method's result.The customer's high ft3 result from the analyzer could be reproduced.An ft3 iii assay was performed and no difference between the ft3 iii test generation could be observed.Upon further investigation of the patient's sample, an interferent against the ruthenium (ru)-label was observed.This interference is covered in product labeling: "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.

Manufacturer Narrative

The patient's sample was further investigated.The presence of an interfering factor against the ruthenium (ru)-label of the ft3 and ft4 assays was confirmed.The investigation also found the sample contained an interference against the streptavidin component of the reagent.

• Brand Name: ELECSYS FT4 III ASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13176920
• MDR Text Key: 284645254
• Report Number: 1823260-2022-00053
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 04/18/2022

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: 541052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 01/03/2022; 02/04/2022; 03/29/2022
• Supplement Dates FDA Received: 01/28/2022; 02/28/2022; 04/18/2022
• 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: NEO-MERCAZOLE.