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

Model Number	FT3 G3
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys ft3 iii and elecsys ft3 iii ver.2 results for 1 patient sample on a cobas e801 module compared to a wako accuraseed analyzer and an abbott architect analyzer.Refer to the attachment to the medwatch for all patient data.No questionable results were reported outside of the laboratory.The customer reagent lots and expiration dates were requested but not provided.The investigational ft3iii lot is 583301 and the expiration date is 28-feb-2023.The investigational ft3iii ver.2 lot is 611920 and the expiration date is 31-may-2023.The customer e801 analyzer serial number is (b)(4).The investigational e801 analyzer serial number is (b)(4).This medwatch will cover ft3iii.Refer to medwatch with patient identifier (b)(6) for information on the ft3iii ver.2 results.
Additional Manufacturer Narrative
The patient's sample was provided for investigation.The investigation found that there is no interference with the streptavidin component of the reagent in the sample.It was also determined that there is no interfering factor against the ft3 antibody idiotype.The influence of prewash use was also not observed.Based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 15939197
• Report Number: 1823260-2022-03937
• Device Sequence Number: 6442594
• 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): N
• 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): 02/20/2023

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: 02/28/2023
• Device Model Number: FT3 G3
• Device Catalogue Number: 07027362190
• Device Lot Number: 583301
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 02/20/2023
• 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 Age: 78 YR
• Patient Sex: Female