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

Model Number FT4 G3

Device Problem Incorrect Measurement (1383)

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

Event Date 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

The sample material was requested for investigation.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft4 iii (ft4 iii) and elecsys ft3 iii (ft3 iii) on a cobas 8000 e 602 module compared to a third party laboratory using an unknown method.This medwatch will cover ft4 iii.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results.The ft4 iii result from the e602 module was 2.87 ng/dl.The result from the external laboratory was 9.28 pmol/l (0.72 ng/dl).The ft3 iii result from the e602 module was 7.32 pg/ml.The result from the external laboratory was 3.73 pmol/l (2.43 pg/ml).The patient takes methimazole.The patient stopped taking the drug for 2 weeks and a new sample was obtained and the patient was re-tested with the following results: the ft4 iii result from the e602 module was 3.34 ng/dl.The result from the external laboratory was 11.9 pmol/l (0.92 ng/dl).The ft3 iii result from the e602 module was 7.85 pg/ml.The result from the external laboratory was 4.29 pmol/l (2.79 pg/ml).The results from the e602 module were reported outside of the laboratory where they were questioned by the clinicians.The e602 module serial number was (b)(4).

Manufacturer Narrative

A sample from the patient was submitted for investigation.The high ft3 and ft4 results were reproduced.Further investigation of the sample determined the patient's sample contained an interfering factor to the ruthenium component of the reagent.This interference caused the patient's high ft3 and ft4 results.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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14676242
• MDR Text Key: 301634550
• Report Number: 1823260-2022-01714
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• 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: 07976836190
• Device Lot Number: 579081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• 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: METHIMAZOLE
• Patient Age: 67 YR
• Patient Sex: Female