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

Model Number	09007733190
Medical Device Problem Codes	High Test Results (2457); Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The qc recovery data provided was acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys t3, elecsys t4 assay, and elecsys tsh assay results for 6 patient samples on a cobas e 801 analytical unit compared to tree competitor analyzers.This medwatch will cover t3.Refer to medwatch with a1 patient identifier (b)(6) for information on the t4 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 units of measurement for the tsh results and for the competitor analyzer results were not provided.The reference ranges for all assays were not provided.
Additional Manufacturer Narrative
Section d4 reagent lot number has been updated.The customer's t3 reference range is 80-200 ng/dl.The customer stated that their qc recovery data was acceptable.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 was found to be consistent with pre-analytical sample handling issues.
Additional Manufacturer Narrative
**udi related data quality updates only** d3 is the initial distributor in the us.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18365973
• Report Number: 1823260-2023-04137
• Device Sequence Number: 15377775
• Product Code: CDP
• UDI-Device Identifier: 07613336171653
• UDI-Public: 07613336171653
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• 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): 08/29/2024

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: 09007733190
• Device Catalogue Number: 09007733190
• Device Lot Number: 704129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 02/13/2024; 08/29/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/29/2024; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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