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

Model Number	FT3 G3
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was requested for further investigation, however, there was not enough sample volume remaining.From the information available, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter questioned thyroid results for 1 patient sample tested on a cobas e801 module.The questionable results were reported outside of the laboratory where the physician requested additional testing.The sample was submitted for investigation where discrepant results were identified for elecsys ft3 iii (ft3 iii) and elecsys tsh (tsh) between the customer¿s e801 module, an e801 module used at the investigation site, a cobas e 411 immunoassay analyzer used at the investigation site and the abbott architect method.This medwatch will cover ft3 iii.Refer to medwatch with patient identifier (b)(6) for information on the tsh results.The customer¿s e801 module was 1752-03.The e801 module serial number used at the investigation site was (b)(4).The e411 analyzer serial number used at the investigation site was (b)(4).The ft3 iii v2 reagent lot number used with the e801 module at the investigation was 611920 with an expiration date of 31-may-2023.The ft3 iii v2 reagent lot number used with the e411 analyzer at the investigation was 573234 with an expiration date of 31-jan-2023.

• Brand Name: ELECSYS FT3 III
• Common Device Name: RADIOIMMUNOASSAY, 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: 16439748
• Report Number: 1823260-2023-00581
• Device Sequence Number: 7400883
• Product Code: CDP
• UDI-Device Identifier: 04015630939718
• UDI-Public: 04015630939718
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963127
• 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): 02/24/2023

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 G3
• Device Catalogue Number: 07027362190
• 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: 01/31/2023
• Initial Report FDA Received Date: 02/24/2023
• 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