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

Model Number	FT3 III
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 module is (b)(6).The patient sample was received for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys ft3 iii ver.2 result from one patient sample tested on a cobas e 801 analytical unit.On (b)(6) 2024: the initial ft3 result from the analyzer was 11.3 pg/ml.The initial result was questioned by the endocrinologist as it was deemed high and did not fit the clinical picture and the tsh and ft4 results of the patient, prompting the rerun of the patient sample.On (b)(6) 2024: the first ft3 repeat result from another e 801 analyzer with the patient sample in a hitachi cup was 9.2 pg/ml.The serum sample tube was treated with a serum separator (valve filter) before the following reruns: the second repeat result from the analyzer was 9.32 pg/ml.The third repeat result from the analyzer was 9.38 pg/ml.The fourth repeat result from the analyzer was 9.48 pg/ml.The result of 9.2 pg/ml or 9.3 pg/ml was confirmed.The reporter suspected interference in the patient sample and would like to know if ft3 results would decrease after treatment with a serum separator (valve filter).
Additional Manufacturer Narrative
The investigation tested the patient sample for the presence of interference.The investigation confirmed the presence in the patient sample of an interfering factor against the ft3 antibody/idiotype of the assay.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: 18855852
• Report Number: 1823260-2024-00690
• Device Sequence Number: 3338026
• Product Code: CDP
• UDI-Device Identifier: 07613336171578
• UDI-Public: 07613336171578
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 05/16/2024

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: 11/30/2024
• Device Model Number: FT3 III
• Device Catalogue Number: 09005811190
• Device Lot Number: 73731401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/16/2024
• 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: ALLOPURINOL.; CARBIMAZOLE 10 MG 1-0-0.; PPI 20 MG 1-0- 0.
• Patient Age: 73 YR
• Patient Sex: Male