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

Model Number	FT3 III
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys ft3 iii results for 1 patient sample on two cobas e 801 module compared to an abbott architect analyzer.Refer to the attachment to the medwatch for all patient data.
Additional Manufacturer Narrative
The customer's analyzer serial number was not provided.The customer's ft3 reagent lot number and expiration date were not provided.The investigation analyzer serial number is (b)(6).The reagent information provided in h10 was used on the investigational analyzer.The customer suspects an interfering factor in the patient sample.The investigation is ongoing.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation did not identify the presence of an interfering factor in the patient sample.The investigation did not identify a product problem.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19153552
• Report Number: 1823260-2024-01220
• Device Sequence Number: 15564691
• Product Code: CDP
• UDI-Device Identifier: 07613336171578
• UDI-Public: 07613336171578
• Combination Product (Y/N): Y
• 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): 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): 06/27/2024

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: 11/30/2024
• Device Model Number: FT3 III
• Device Catalogue Number: 09005811190
• Device Lot Number: 737314
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 32 YR
• Patient Sex: Female