MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; TOTAL TRIIODOTHYRONINE

Catalog Number	09005803190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned the thyroid results for 1 patient sample tested on a cobas e 411 immunoassay analyzer compared to competitor methods.Discrepant results were identified for elecsys ft4 iv (ft4 iv), elecsys ft3 iii (ft3 iii), and elecsys anti-tshr (anti-tshr) between the customer¿s e411 analyzer, the abbott alinity method, the fujirebio lumipulse method and an e411 analyzer used at the investigation site.This medwatch will cover ft3 iii.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft4 iv results and medwatch with a1 patient identifier (b)(6) for information on the anti-tshr results.Refer to the attached data for the patient results.
Additional Manufacturer Narrative
The customer¿s e411 analyzer serial number was not provided.The e411 analyzer serial number used at the investigation site was (b)(6).The ft3 iii reagent lot number used at the investigation site was 686656 with an expiration date of 30-apr-2024.
Additional Manufacturer Narrative
The sample was not submitted for further investigation.Since the sample could not be investigated further, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS FT3 III
• Common Device Name: TOTAL TRIIODOTHYRONINE
• 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: 17789391
• Report Number: 1823260-2023-03045
• Device Sequence Number: 15066563
• Product Code: CDP
• UDI-Device Identifier: 07613336171585
• UDI-Public: 07613336171585
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 10/02/2023

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: 04/30/2024
• Device Catalogue Number: 09005803190
• Device Lot Number: 686656
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/02/2023
• 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