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

Model Number	09043284190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys ft3 iii and elecsys ft4 iv results from one patient sample tested on the customer's cobas e 801 module, and the investigation site's cobas e 801 and cobas e 411 modules.This mdr is for the ft4 iv assay.Please refer to medwatch with a1 - patient identifier (b)(6) for the ft3 iii assay.The date the information was received was used as the date of the event.The patient sample was sent to the investigation site that uses a cobas e 801 and an e 411 and an outsourced laboratory that uses an abbott architect; discrepant results were noted.Please refer to the attachment in the medwatch (b)(6) for the highlighted questionable results.
Additional Manufacturer Narrative
The serial number of the customer's e 801 module is unknown.The serial number of the investigation site's e 801 module is c231-05.The serial number of the investigation site's e 411 module is 65g1-25.The ft4 iv reagent lot number used at the investigation site's e 801 is 669112 with an expiration date of 29-feb-2024.The ft4 iv reagent lot number used at the investigation site's e 411 is 670634 with an expiration date of 30-nov-2023.The patient sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation was able to reproduce the customer's ft3 and ft4 results.The investigation tested the patient sample for the presence of an interferent.The investigation confirmed the presence of an interferent against the ft3 antibody/idiotype.Product labeling states "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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.
Additional Manufacturer Narrative
**udi related data quality updates only** d3 is the initial distributor in the us.

• 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 46250-0457
• MDR Report Key: 18129779
• Report Number: 1823260-2023-03594
• Device Sequence Number: 6628248
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 08/29/2024

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 Model Number: 09043284190
• Device Catalogue Number: 09043284190
• Device Lot Number: ASKU, 669112, 670634
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 03/21/2024; 08/29/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 04/11/2024; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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