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

Model Number	FT4 IV
Medical Device Problem Codes	Incorrect Measurement (1383); Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Summary of investigation results: the investigation is ongoing.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.There was an allegation of questionable elecsys ft4 iv results for approximately 60 samples from the cobas e 801 analytical unit.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.
Additional Manufacturer Narrative
1.Summary of investigation results: the investigation determined that the event was due to a handling/storage issue of the reagent pack by the customer, as the reagent pack had been frozen.The customer did not perform qc on the reagent pack in question prior to use.Good laboratory practice precludes running and/or reporting patient results when quality control has not been performed.A general reagent problem can be excluded.2.Summary of follow-up/corrective actions taken: there were no follow-up/corrective actions taken.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21925113
• Report Number: 1823260-2025-01319
• Device Sequence Number: 18325086
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (Y/N): N
• PMA/510(K) Number: K220456
• 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): 06/04/2025

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 Model Number: FT4 IV
• Device Catalogue Number: 09043284190
• Device Lot Number: 79774400
• 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: 06/04/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/04/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown