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

Model Number	FT3 G3
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys ft3 iii and elecsys ft3 iii ver.2 results from one patient sample tested on the customer's cobas e 801 module with serial number (b)(4) and the investigation site's cobas e 801 module with serial number (b)(4).This mdr is for the ft3 iii assay.Refer to: medwatch with a1 - patient identifier (b)(6) for the ft3 iii v2 assay.The exact date of the event is unknown.The date the information was received was used as the date of the event.The initial results were reported outside of the laboratory.The physician asked for the sample to be rerun at the investigation site.The investigation site uses an e 411 and e 801.It was also sent to an outsourced laboratory that uses an abbott architect.The ft3 iii reagent was used at the investigation site's e 801.Refer to the attachment in the medwatch for the highlighted questionable results.
Additional Manufacturer Narrative
Na.
Additional Manufacturer Narrative
With the recently introduced ft3iii v2 assay version, all values are significantly lower compared to the values generated with the ft3iii assay version, as the ft3iii v2 assay has improved robustness against streptavidin interference.The differences in the ft3 values ¿ in between the cobas e 411 analyzer and the cobas e 801 module ¿ most likely depends on the differences in the physical setups of the analyzers and the effect thereof on the streptavidin interference factor.The investigation determined that a streptavidin-interfering factor caused the falsely elevated value of the ft3iii assay version.Product labeling states "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." from the information provided and the analysis thereof, a general reagent issue most likely can 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: 16101240
• Report Number: 1823260-2023-00053
• Device Sequence Number: 15009515
• 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,Followup
• Report Date (Section B): 02/16/2023

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: 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: 12/08/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/16/2023
• 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
• Patient Sex: Unknown