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

Model Number	FT3 III
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a general reagent issue can be excluded.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and the standardization methodology used.The investigation did not identify a product problem.
Event or Problem Description
The initial reporter stated they received discrepant results for 1 patient¿s sample tested with elecsys tsh v2 (tsh v2) assay, elecsys ft4 g4 (ft4 iv) assay and elecsys ft3 g3 v2 (ft3 iii v2) assay on a cobas e801 module and on a cobas e411 module.From the sample, there were 1 discrepant result for tsh v2 test, 1 discrepant result for ft4 iv test and 1 discrepant result for ft3 iii v2 test.This medwatch will apply to the ft3 iii v2 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the tsh v2 assay and to the medwatch with a1.Patient identifier (b)(6) for information related to the ft4 iv assay.Refer to the attachment for the patient¿s data.On 27-apr-2023 the sample was initially tested on the customer's e801 analyzer and repeated on the same analyzer.The questionable results were reported outside the laboratory.On 28-apr-2023 the sample was then provided for investigation where it was tested on a 2nd e801 analyzer and on an e411 analyzer.On 9-may-2023 the sample was also repeated on an abbott architect analyzer.The serial number of the customer's e801 analyzer was not provided.The ft3 iii v2 reagent lot number and expiration date were requested but not provided.The tsh v2 reagent lot number and expiration date were requested but not provided.The ft4 iv reagent lot number and expiration date were requested but not provided.The ft4 iii reagent lot number and expiration date were requested but not provided.The serial number of the e801 analyzer used for investigation was (b)(4).The ft3 iii v2 reagent lot number was 611920.The expiration date was not provided.The tsh v2 reagent lot number was 674689.The expiration date was not provided.The ft4 iv reagent lot number was 670634.The expiration date was not provided.The ft4 iii reagent lot number was 630888.The expiration date was requested but not provided.The serial number of the e411 analyzer used for investigation was (b)(4).The ft3 iii v2 reagent lot number was 611918.The expiration date was not provided.The tsh v2 reagent lot number was 660341.The expiration date was not provided.The ft4 iv reagent lot number was 663936.The expiration date was not provided.All reagents' lots were well within their life-cycle at the time of the event.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17064977
• Report Number: 1823260-2023-01857
• Device Sequence Number: 5886118
• Product Code: CDP
• UDI-Device Identifier: 07613336171585
• UDI-Public: 07613336171585
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 06/05/2023

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 Model Number: FT3 III
• Device Catalogue Number: 09005803190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 06/05/2023
• 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