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

Model Number	FT3 G3
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2023 the customer compared sample 1 to another sample after adding peg treatment.Refer to the attachment for the patient¿s data.The serial number of the cobas e 801 analytical unit was not provided.The sample was requested for investigation.Investigation is ongoing.H3 other text : na.
Event or Problem Description
The initial reporter stated they received discrepant results for 1 patient¿s sample tested with elecsys ft3 g3 (ft3 iii) assay on a cobas e801 analytical unit compared to a non-roche analyzer (abbott).Refer to the attachment for the patient¿s data.The physician doubted the ft3 iii result and later that day, he ordered a new ft3 iii test using a new sample.Then 3 samples were collected from the same patient at different time points and tested.The sample was then sent to a different laboratory and was tested on an abbott analyzer.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation confirmed the customer's elevated ft3 iii result.The investigation performed interference analyses.The investigation determined that the event was caused by an interfering factor against the antibody/idiotyp of the elecsys ft3 iii assay in the patient sample.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.
Additional Manufacturer Narrative
The requested sample was provided for investigation.Investigation is ongoing.

• Brand Name: ELECSYS FT3 III
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17194398
• Report Number: 1823260-2023-02072
• Device Sequence Number: 7461868
• Product Code: CDP
• UDI-Device Identifier: 04015630939718
• UDI-Public: 04015630939718
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K963127
• 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,Followup
• Report Date (Section B): 09/27/2023

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 Model Number: FT3 G3
• Device Catalogue Number: 07027362190
• Device Lot Number: 669112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 06/30/2023; 09/01/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/21/2023; 09/27/2023
• 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: ASPIRIN 81 MG ENTERIC COATED TABLET.; ATORVASTATIN 40 MG TABLET.; GABAPENTIN 300 MG CAPSULE.; HERBAL MEDICINE.
• Patient Age: 78 YR
• Patient Sex: Male