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

Model Number	09007733190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys t3, elecsys t4 assay, elecsys ft3 iii, elecsys ft4 iii assay, elecsys anti-tpo, and elecsys anti-tg results for 1 patient sample on a cobas e 801 module compared to an abbott analyzer.This medwatch will cover t3.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results, medwatch with a1 patient identifier (b)(6) for information on the t4 results, medwatch with a1 patient identifier (b)(6) for information on the ft4 iii results, medwatch with a1 patient identifier (b)(6) for information on the anti-tpo results, and medwatch with a1 patient identifier (b)(6) for information on the anti-tg results.Refer to the attachment to the medwatch for all patient data.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The patient sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
No patient sample was available for investigation.The investigation did not identify a product problem.The root cause of the event could not be determined.
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: 18335905
• Report Number: 1823260-2023-04034
• Device Sequence Number: 8425057
• Product Code: CDP
• UDI-Device Identifier: 07613336171653
• UDI-Public: 07613336171653
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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 Expiration Date: 07/31/2024
• Device Model Number: 09007733190
• Device Catalogue Number: 09007733190
• Device Lot Number: 70412901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/11/2024; 08/29/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/30/2024; 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