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	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient sample was requested for investigation.
Event or Problem Description
The initial reporter received questionable elecsys ft3 iii assay and elecsys ft3 iii ver.2 results from one patient sample tested on the customer's cobas e 801 module with serial number: (b)(4), the investigation site's e 411 with serial number: (b)(4) and the investigation site's e 801 with serial number: (b)(4).This medwatch is for the ft3 iii assay.Please refer to medwatch with patient identifier: (b)(6) for the ft3 iii v2 assay.The reporter alleged that the ft3 result did not match the patient's clinical situation and that the thyroid data were imbalanced.The reporter suspects a falsely high ft3 result and some nonspecific interference in roche assays.The reporter requested measurement of the patient sample at an investigation site.It was also sent out to an outsourced laboratory.The reporter was not able to provide the date of measurement at the customer site.The date of blood sampling was used as the date of the event.The initial results were not reported outside of the laboratory.Please refer to the attachment "pt-80290 " for the highlighted questionable results.The ft3 iii reagent lot number used at the investigation site's e 411 is 585947 with an expiration date of 28-feb-2023.The ft3 iii reagent lot number used at the investigation site's e 801 is 583301 with an expiration date of 28-feb-2023.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation was not able to confirm the results of the different assay versions of ft3 iii from the investigation laboratory and an e 801 module.The investigation was able to confirm the different ft3 iii assay results from the e 801 module and the e 411 analyzer.The investigation confirmed the presence of a small biotinol-depending interference.The investigation also confirmed the presence of streptavidin interference.The investigation determined that the event was caused by the streptavidin interference factor in the 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.".

• 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: 16603204
• Report Number: 1823260-2023-00949
• Device Sequence Number: 5924031
• Product Code: CDP
• UDI-Device Identifier: 04015630939718
• UDI-Public: 04015630939718
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/13/2023

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 Expiration Date: 02/28/2023
• Device Model Number: FT3 G3
• Device Catalogue Number: 07027362190
• Device Lot Number: 585947, 583301
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 07/13/2023
• 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: LEVOTHYROXINE SODIUM.
• Patient Sex: Unknown