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

Catalog Number	09005803190
Medical Device Problem Codes	High Test Results (2457); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem 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 other methods.This medwatch will cover ft3 iii.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft4 iii results.The ft4 iii result from the e602 module was 24.11 pmol/l.On (b)(6) 2023 the result from the beckman method was 0.64 pmol/l.On (b)(6) 2023 the result from the autibio method was 14.47 pmol/l.The ft3 iii result from the e602 module was 10.57 pmol/l.On (b)(6) 2023 the result from the beckman method was 3.30 pmol/l.On (b)(6) 2023 the result from the autibio method was 5.55 pmol/l.The customer suspects an interference affecting the roche results.
Additional Manufacturer Narrative
Section e1 facility name continued: (b)(6).The sample was requested for investigation.
Additional Manufacturer Narrative
The sample was received for investigation.The customer's high ft4 iii and ft3 iii results were reproduced.Upon further investigation of the patient sample, an interferent against the ruthenium component of the reagent was confirmed.This caused the high ft3 iii and ft4 iii 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 FT3 III
• Common Device Name: 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: 17661753
• Report Number: 1823260-2023-02837
• Device Sequence Number: 17909337
• Product Code: CDP
• UDI-Device Identifier: 07613336171585
• UDI-Public: 07613336171585
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 09005803190
• Device Lot Number: 660556
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PTU
• Patient Age: 59 YR
• Patient Sex: Male