MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T3; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number	T3
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys t3 results for 1 patient sample on a cobas e 801 analytical unit.This medwatch will cover t3.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 results, medwatch with a1 patient identifier (b)(6) for information on the ft4 results, and medwatch with a1 patient identifier (b)(6) for information on the tsh results.Refer to the attachment to the medwatch for all patient data.The initial results were reported outside of the laboratory.The doctor questioned the results as they did not match the patient's clinical picture.The analyzer serial number is (b)(6).
Additional Manufacturer Narrative
Sections d4 and g4 have been updated.
Additional Manufacturer Narrative
The calibration and qc provided was acceptable.It was determined that the result differences generated between the different methods are consistent with methodological differences.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and the standardized methodology used.The investigation did not identify a product problem.

• Brand Name: ELECSYS T3
• 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: 16955691
• Report Number: 1823260-2023-01675
• Device Sequence Number: 7012692
• Product Code: CDP
• UDI-Device Identifier: 07613336171653
• UDI-Public: 07613336171653
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962508
• 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,Followup,Followup
• Report Date (Section B): 08/21/2023

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: T3
• Device Catalogue Number: 09007733190
• Device Lot Number: 622585
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 07/26/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/16/2023; 08/21/2023
• 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: 73 YR
• Patient Sex: Male