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

Model Number	09043284190
Medical Device Problem Codes	High Test Results (2457); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ft4 iv reagent's lot number that was also used was 724974 with an expiration date of 31-may-2024.The ft3 reagent's lot number and expiration date were not provided.The cobas e801 module serial number was (b)(6).The patient's sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for 1 patient¿s sample tested with elecsys ft4 g4 (ft4 iv) assay and ft3 g3 (ft3 iii) assay on a cobas 8000 e801 immunoassay analyzer when compared to a competitor's (abbott) method.This medwatch will apply to the ft4 iv assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft3 iii assay.Refer to the attachment for all patient data.The physician questioned the initial results for ft4 iv and ft3 iii.
Additional Manufacturer Narrative
The medical device problem code was updated.The sample was provided for investigation.The customer's ft4 values above the reference range could be reproduced.A prewash effect could not be seen.The customer's ft3iii value slightly above the upper level of the normal reference range was generated.Interference analysis - streptavidin agent (sa) component interference analysis was carried out with sa toolbox (a-tg) on cobas e411 to check if an interfering factor against sa (streptavidin) could be present in this sample.A reagent without sa-interference blocking agent and a reagent with sa-interference blocking agent were used for comparative measurement.The results of both a-tg kits were comparable.No difference between the signal values could be seen.Interference - ft4 and ft3 with bpru interference analysis was carried out with ft4 and ft3 on cobas e411 to check if an interfering factor against sulforu-label could be present.R&d research kits with modified ru-label ("old" test generation) were used for comparative measurement.Within this interference analysis, no interfering factor against sulforu-label could be identified as no difference between concentration values using sales lots and using r&d research kits could be seen.An interfering factor against sa and ru-label could be excluded as no difference in signal and concentration values could be observed with the investigated assays.The investigation of the sample with several research toolboxes determined that no assay interfering factors for the ft4iv and ft3iii assays were detected.The investigation did not identify a product problem.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.
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
• MDR Report Key: 18129340
• Report Number: 1823260-2023-03590
• Device Sequence Number: 20728147
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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 Expiration Date: 11/30/2023
• Device Model Number: 09043284190
• Device Catalogue Number: 09043284190
• Device Lot Number: 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: 12/07/2023; 08/29/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/27/2023; 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 Age: 23 YR
• Patient Sex: Male