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

Catalog Number	09005021190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The anti-tg reagent lot number 87798201 had an expiration date of 31-jul-2026.The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for an unspecified number of patients' samples tested with elecsys anti-tg assay on a cobas e 801 analytical unit, not correlating with the patients' clinical status.The customer alleged that the initial results for the thyroidectomized patients were estimated to be 20 to 29 iu/ml (which were higher than the expected values) and that they did not match the patients' previous results of <18 iu/ml.No exact values for the initial results were provided.Discrepant results for 1 patient sample were provided: on (b)(6) 2025: initial result: 21 iu/ml.On (b)(6) 2025: repeat result: 28 iu/ml.
Additional Manufacturer Narrative
A general reagent problem can be excluded.The given shift/deviation was within the normal standardization specification.The investigation did not identify a product problem.The standardization specifications were met.

• Brand Name: ELECSYS ANTI-TG
• Common Device Name: THYROID AUTOANTIBODY TEST SYSTEM
• 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: 23621616
• Report Number: 1823260-2025-04790
• Device Sequence Number: 13029726
• Product Code: JZO
• UDI-Device Identifier: 07613336171479
• UDI-Public: 07613336171479
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K053426
• 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): 03/20/2026

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 09005021190
• Device Lot Number: 84585101, 87798201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 03/20/2026
• 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
• Patient Sex: Unknown