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	08/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys ft3 iii and elecsys ft3 iii ver.2 results for one patient sample tested on the customer's cobas 8000 e801 module with serial number (b)(4), the investigation site's cobas 8000 e801 module with serial number (b)(4) and the investigation site's e 411 with serial number (b)(4).This mdr is for the ft3 iii assay.Refer to the medwatch with patient identifier (b)(6) for the ft3 iii v2 assay.The initial result was not reported outside of the laboratory.The reporter suspected non-specific interference in the roche thyroid assays.The patient sample was then rerun in their wako accuraseed analyzer.It was also sent to the investigation site and an outsourced laboratory that uses an abbott architect.The ft3 iii reagent lot used in the investigator site's e 801 is 551720 with an expiration date of (b)(6) 2022.The ft3 iii reagent lot used in the investigator site's e 411 is 585947 with an expiration date of (b)(6) 2022.Refer to the attachment in the medwatch for the highlighted questionable results.
Additional Manufacturer Narrative
The investigation determined that with the recently introduced ft3iii v2 assay version, the value generated with the cobas e 411 analyzer is within the normal reference range of the assay.This value is similar to the values generated with the ft3 assays from the abbott and wako analyzers.As the ft3iii v2 assay version has improved robustness against streptavidin interference, the root cause of the discrepant high values of the ft3iii assay version most likely relates to the presence of a streptavidin interference factor that caused the falsely elevated value of the ft3iii assay version.The differences in the ft3 iii v2 values of the cobas e 411 analyzer and the cobas e 801 module most likely depend on the differences in the physical setups of the analyzers.A possible effect of the physical setup of the cobas e 801 module remains to exist for the ft3 iii v2 assay version.The falsely elevated value of the ft3 iii assay version most likely is caused by streptavidin interference.This is corrected by the recently introduced ft3iii v2 assay version for the cobas e 411 analyzer.The differences in the ft3 iii v2 values of the cobas e 411 analyzer and the cobas e 801 module most likely depends on the differences in the physical setups of the analyzers.A possible effect of the physical setup of the cobas e 801 module remains to exist for the ft3 iii v2 assay version.From the information provided and the analysis thereof, a general reagent issue can most likely be excluded.

• 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: 15670177
• Report Number: 1823260-2022-03352
• Device Sequence Number: 15045988
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2022

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: 09/30/2022
• Device Model Number: FT3 G3
• Device Catalogue Number: 07027362190
• Device Lot Number: 551720, 585947
• 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: 09/27/2022
• Initial Report FDA Received Date: 10/25/2022
• 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
• Patient Age: 18 YR
• Patient Sex: Female