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

Catalog Number	08906564190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys tg ii results from two patient samples tested on the cobas e 801 analytical unit.One example of discrepant results was provided: the initial result from the analyzer was 0.136 ng/ml with a data flag.The first repeat result from the analyzer was 0.347 ng/ml.The doctor deemed the result too high for the patient.The second repeat result from another roche analyzer was < 0.0400 ng/ml with a data flag.This result was deemed correct.
Additional Manufacturer Narrative
The investigation included a review of the data set provided by the customer: the calibration and qc results were within the specified ranges.The alarm trace did not indicate any issues.A general reagent problem was not detected because the qc before the event was within ranges, and non-systematic and non-reproducible results do not represent a general malfunction of the assay.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 22893182
• Report Number: 1823260-2025-02609
• Device Sequence Number: 5986408
• Product Code: MSW
• UDI-Device Identifier: 07613336169582
• UDI-Public: 07613336169582
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 10/28/2025

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: 02/28/2026
• Device Catalogue Number: 08906564190
• Device Lot Number: 85444701
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/28/2025
• 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