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

Model Number FT4 G2

Device Problem Low Test Results (2458)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

The initial reporter complained of results not corresponding to the clinical picture for 1 patient tested for elecsys ft4 ii assay (ft4 ii) and elecsys ft3 iii (ft3 iii) on a cobas 8000 e 602 module.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results.On (b)(6) 2021 the patient had an ft4 ii result of 3.1 pmol/l and an ft3 iii result of < 0.4 pmol/l.On (b)(6) 2021 the patient had an ft4 ii result of 3.86 pmol/l and an ft3 iii result of < 0.4 pmol/l.The results were reported outside of the laboratory.The results suggested secondary hypothyroidism; this did not match the patient¿s clinical diagnosis.The e602 module serial number was (b)(4).

Manufacturer Narrative

On an unknown date the patient was tested by the beckman method with the following results (the units of measure were not provided): tsh: 0.89, t3: 0.8, t4: 88.6, ft3: 2.6, ft4: 0.99, anti-tg: 2.16, anti-tpo: <0.01.

Manufacturer Narrative

For the beckman results provided on the initial report, the unit of measure for ft3 was pg/ml and the unit of measure for ft4 was ng/dl.A new sample from the patient was submitted for investigation.The customer's low ft4 and ft3 results were reproduced.Further investigation of the sample confirmed an interference against the ruthenium component of both the ft4 and ft3 assays.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.

• Brand Name: ELECSYS FT4 II 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: 13307430
• MDR Text Key: 291366464
• Report Number: 1823260-2022-00164
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961489
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: FT4 G2
• Device Catalogue Number: 06437281190
• Device Lot Number: 547168
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• 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