MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4; RADIOIMMUNOASSAY, TOTAL THYROXINE

Model Number	T4
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys t3 and elecsys t4 assay results from two patient samples tested on the cobas e 801 module with unknown serial number.The reporter stated that the results they obtained from the module were significantly higher than those from an abbott system.The initial results were not reported outside of the laboratory.This medwatch is for the t4 assay.Please refer to medwatch with patient identifier: (b)(6) for the t3 assay.Please refer to the attachment in the medwatch for the table containing the questionable results.The reporter stated that the results from each method were not presenting the same clinical interpretation.
Additional Manufacturer Narrative
The patient samples are not available for investigation.Qc data for t3 was acceptable.Based on the information provided, a general reagent issue can most likely be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS T4
• Common Device Name: RADIOIMMUNOASSAY, TOTAL THYROXINE
• 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: 16631540
• Report Number: 1823260-2023-00999
• Device Sequence Number: 20150795
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K961490
• 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): 03/28/2023

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: T4
• Device Catalogue Number: 09007784190
• Device Lot Number: 653184
• 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: 03/01/2023
• Initial Report FDA Received Date: 03/28/2023
• 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