MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Model Number	FT4 IV
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was 918716 with an expiration date of 31-dec-2026.The investigaiton is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys ft4 iv results from the cobas e 801 analytical unit.Approximately 30 samples had an initial ft4 result > 20 ng/l.When repeated, the result was within the normal range.One example was provided of an initial result of 25.3 ng/l, and a repeat result of 10.8 ng/l.An estimated example was an initial result of 25 ng/l., and a repeat result of 8 ng/l.The samples were repeated on the same analyzer or on another cobas pro analyzer at the customer site.The lower (repeat) results were reported outside of the laboratory and were consistent with the patients' history.
Additional Manufacturer Narrative
Medwatch fields d1-d4, g1, and g4 were updated.Based on the provided calibration data, there were multiple events with unusually high calibration signals and/or duplication errors.This is consistent with customer calibration handling issues such as aliquoting, storage, homogenization, bringing the materials to room temperature prior to use, and adherence to single-use.As the calibration issues were not related to a certain reagent or calibration lot, a general reagent or calibrator issue was excluded.It was noted on the day of the event that the quality control was either incomplete or not performed.Good laboratory practice precludes running and/or reporting patient results when quality control has not been performed.No product issue was found.

• Brand Name: ELECSYS FT4 IV
• Common Device Name: FREE THYROXINE
• 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 46250-0457
• MDR Report Key: 24598672
• Report Number: 1823260-2026-00916
• Device Sequence Number: 18234076
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K220456
• 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): 04/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FT4 IV
• Device Catalogue Number: 09043284190
• Device Lot Number: 918716
• 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: 02/21/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/23/2026
• 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 Sex: Unknown