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

Model Number	FT3 G3
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the information provided and the analysis thereof, a general reagent issue can most likely be excluded.The differences generated between the different methods most likely relate to methodological differences.To the differences in the values generated with the different analyzers, it needs to be taken into account that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.In case a sample is analyzed with different analyzers, the generated values are to be interpreted in relation to the normal reference ranges of the assays of the different analyzers.
Event or Problem Description
The initial reporter received questionable elecsys ft3 iii and elecsys ft3 iii ver.2 results for one patient sample tested on the customer's cobas 8000 e 801 module with an unknown serial number and the investigation site's cobas 8000 e 801 module with serial number (b)(6).This mdr is for the ft3 iii assay.Refer to the medwatch with patient identifier (b)(6) for the ft3 iii v2 assay.The initial results were not reported outside of the laboratory.The reporter sent the patient sample to the investigation site due to an imbalance of thyroid test results.It was also sent to an outsourced laboratory that uses an abbott architect for reruns.Refer to the attachment in the medwatch for the highlighted questionable results.

• 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: 15780879
• Report Number: 1823260-2022-03582
• Device Sequence Number: 14676913
• 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
• Report Date (Section B): 11/11/2022

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: 10/13/2022
• Initial Report FDA Received Date: 11/11/2022
• 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