MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TSHR; THYROID AUTOANTIBODY TEST

Catalog Number	08496633190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).Sample material from the patient was requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys anti-tshr results from the cobas e 801 analytical unit.The customer suspected an interference.The patient's results have been significantly elevated and do not match the patient's clinical presentation.One anti-tshr result of 25.50 iu/l was provided.
Additional Manufacturer Narrative
Sample material from the patient was not provided for investigaiton.The customer sent the sample to another laboratory with an independent method, which confirmed the positive result (34.6 iu/l), which confirmed the customer's result.The investigation excluded a general reagent problem.No product problem found.

• Brand Name: ELECSYS ANTI-TSHR
• Common Device Name: THYROID AUTOANTIBODY TEST
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24489371
• Report Number: 1823260-2026-00750
• Device Sequence Number: 14706645
• Product Code: JZO
• UDI-Device Identifier: 07613336160329
• UDI-Public: 07613336160329
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K193313
• 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
• Report Date (Section B): 05/22/2026

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 Catalogue Number: 08496633190
• Device Lot Number: 90895303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/22/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EUTHYROX (LEVOTHYROXINE SODIUM)
• Patient Age: 46 YR
• Patient Sex: Unknown