MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; TOTAL TRIIODOTHYRONINE

Catalog Number 09005811190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e801 module serial number was (b)(6).The sample was provided for investigation on 1(b)(6) 2023.The investigation is ongoing.

Event Description

We received an allegation about discrepant results for 1 patient's sample tested with elecsys ft3 g3 (ft3 iii) assay on a cobas e801 immunoassay analyzer when compared to a competitor's (abbott) analyzer (architect).On (b)(6) 2023 the sample was tested on e801 module.Initial result: 7.52 pg/ml (reference range: 2.0 - 4.4 pg/ml).On (b)(6) 2023 the same sample was then repeated on architect.Repeat result: 3.47 pg/ml (reference range: 1.58 - 3.91 pg/ml).

Manufacturer Narrative

The investigation of the provided sample detected an interfering factor against the streptavidin component of the assay causing the falsely elevated value of the ft3iii assay.The investigation did not identify a product problem.The root cause was due to the detected interfering factor against the streptavidin component of the assay.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.

• Brand Name: ELECSYS FT3 III
• Type of Device: TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18183020
• MDR Text Key: 328755330
• Report Number: 1823260-2023-03734
• Device Sequence Number: 1
• Product Code: CDP
• UDI-Device Identifier: 07613336171578
• UDI-Public: 07613336171578
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 09005811190
• Device Lot Number: 669112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• 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: 50 YR
• Patient Sex: Male