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

Model Number	FT4 IV
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation was able to confirm the customer's ft3 and ft4 results.Upon further investigation of the patient sample, an interferent against the ruthenium component of the reagent was confirmed.This interference is covered in product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." the investigation did not identify a product problem.
Event or Problem Description
There was an allegation of questionable elecsys ft3 iii and elecsys ft4 iv assay results for 1 patient sample on a cobas e 801 module.This medwatch will cover ft4 iv.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results.The doctor questioned the roche results which prompted the customer to repeat the sample on a competitor analyzer.The sample had a roche ft3 result of 8.20 pmol/l and a roche ft4 result of 1.98 ng/dl.The roche ft3 reference range is 3.1 - 6.8 pmol/l.The roche ft4 reference range is 0.92 - 1.68 ng/dl.The sample had an abbott ft3 result of 4.58 pmol/l and an abbott ft4 result of 11.2 pmol/l.The abbott ft3 reference range is 2.43 - 6.00 pmol/l.The abbott ft4 reference range is 9.01 - 19.05 pmol/l.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The sample was requested for investigation.The investigation is ongoing.

• 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: 19153802
• Report Number: 1823260-2024-01223
• Device Sequence Number: 12631846
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• 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): 07/02/2024

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: 10/31/2024
• Device Model Number: FT4 IV
• Device Catalogue Number: 09043284190
• Device Lot Number: 74937202
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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 Sex: Unknown