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

Model Number	FT3 III
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Summary of investigation results: the investigation is ongoing.Summary of follow-up/corrective actions taken: the investigation is ongoing.Device returned to manufacturer? no.Device labeled "for single use?" no.Device reprocessed and reused? no.
Event or Problem Description
Describe the event: the initial reporter complained of discrepant results for 2 patients tested for elecsys ft3 iii on a cobas e 411 analyzer (rack system).Patient age range: asku.Patient weight range: asku.Patient sex breakdown: asku.Patient race breakdown: asku.Patient ethnicity breakdown: asku.
Additional Manufacturer Narrative
For the one (1) event summarized: 1.Summary of investigation results: the investigation determined that the event was consistent with the customer's incorrect calibration frequency (more than 28 days) and the customer's non-performance of qc before the patient sample run.Product labeling states: "renewed calibration is recommended as follows: after 1 month (28 days) when using the same reagent lot.After 7 days (when using the same reagent kit on the analyzer).As required: e.G.Quality control findings outside the defined limits." "quality control: controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit, and following each calibration." the investigation did not identify a product problem.2.Summary of follow-up/corrective actions taken: the investigation reviewed the data set provided by the customer: the 28-apr-2025 calibration was acceptable.The 01-jun-2025 calibration had results below the expected ranges.The customer did not perform qc before the patient sample was run.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22586707
• Report Number: 1823260-2025-02258
• Device Sequence Number: 14578271
• Product Code: CDP
• UDI-Device Identifier: 07613336171585
• UDI-Public: 07613336171585
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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?: No
• Device Expiration Date: 09/30/2025
• Device Model Number: FT3 III
• Device Catalogue Number: 09005803190
• Device Lot Number: 80191700
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown