MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TG II; THYROGLOBULIN TEST SYSTEM

Catalog Number	08906564190
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys tg ii results for 1 patient on a cobas 6000 e601 module.The customer has a medical history of total thyroidectomy and has had consistent previous tg results of <0.04 ng/ml since 2021.On (b)(6) 2025, the initial result was 26.27 ng/ml.The repeat result was 27.99 ng/ml.The patient questioned the results and they went to another laboratory to have a new sample collected.The tg result from the other laboratory was <0.04 ng/ml.The exact date of testing was not provided.On (b)(6) 2025, the patient had a new sample collected and tested at the customer site.And the tg result was <0.04 ng/ml with flag.On (b)(6) 2025, the customer repeated the sample from (b)(6) 2025 and the result was 27.76 ng/ml.The sample from (b)(6) 2025 was also repeated and the result was <0.04 ng/ml with flag.
Additional Manufacturer Narrative
Calibration data was acceptable.All three control levels were within range on 06-nov-2025.Only the third level of control was measured on 03-dec-2025 and it was acceptable.For the remaining provided control data, no abnormalities or outliers were observed.Based on calibration and control data, a general reagent issue can be excluded.The investigation could not identify a product problem.The issue is consistent with a pre-analytic sample handling issue or contamination.

• Brand Name: ELECSYS TG II
• Common Device Name: THYROGLOBULIN 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: 23838443
• Report Number: 1823260-2025-05196
• Device Sequence Number: 9959302
• Product Code: MSW
• UDI-Device Identifier: 07613336169582
• UDI-Public: 07613336169582
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K221890
• 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): 03/02/2026

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: 08906564190
• Device Lot Number: 885226
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/02/2026
• 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: GLUNAC; PANTOPRAZOLE; PURAN; SIMVASTATIN; VITAMIN D
• Patient Age: 78 YR
• Patient Sex: Unknown