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

Model Number	FT3 III
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Summary of investigation results: two samples were received for investigation.2.Summary of follow up/corrective actions taken: the investigation is ongoing.3.Device returned to manufacturer? no.4.Device labeled "for single use?" no.5.Device reprocessed and reused? no.
Event or Problem Description
1.Describe the event: there was an allegation about questionable results for 1 patient tested for elecsys ft3 iii on a cobas e411 immunoassay analyzer (disk system) and on a cobas e801 immunoassay analyzer when compared to the abbott assay.2.Patient age range: asku.3.Patient weight range: asku.4.Patient sex breakdown: asku.5.Patient race breakdown: asku.6.Patient ethnicity breakdown: asku.

• 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: 25002175
• Report Number: 1823260-2026-01643
• Device Sequence Number: 21275526
• 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
• Report Date (Section B): 04/27/2026

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: 03/31/2026
• Device Model Number: FT3 III
• Device Catalogue Number: 09005803190
• Device Lot Number: 841738
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown