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	12/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient sample was not available for investigation.The investigation did not identify a product problem.The cause of the event could not be determined. .
Event or Problem Description
The initial reporter received questionable elecsys ft4 iii assay and elecsys ft3 iii ver.2 results from two samples from the same patient tested on the customer's cobas 8000, cobas e 602 module with serial number (b)(4), the investigation site's e 411 with serial number (b)(4) and the investigation site's e 601 with serial number (b)(4).This is for the ft3 iii assay.Please refer to with patient identifier (b)(6) for the ft4 iii assay.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.The ft3 iii v2 reagent lot number used at the customer's laboratory is 573234.The expiration date was requested but not provided.The ft3 iii v2 reagent lot number used at the investigation site's e 411 is 573234 with an expiration date of 31-jan-2023.The ft3 iii v2 reagent lot number used at the investigation site's e 601 is 573234 with an expiration date of 31-jan-2023.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16373413
• Report Number: 1823260-2023-00453
• Device Sequence Number: 6908396
• Product Code: CDP
• UDI-Device Identifier: 07613336171585
• UDI-Public: 07613336171585
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 02/14/2023

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 III
• Device Catalogue Number: 09005803190
• Device Lot Number: 573234
• 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: 01/16/2023
• Initial Report FDA Received Date: 02/14/2023
• 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: Female