MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T GEN 5; TROPONIN SUBUNIT IMMUNOASSAY METHOD

Catalog Number	08469890160
Medical Device Problem Codes	High Test Results (2457); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys troponin t gen 5 result for a patient sample tested on a cobas e 411 analyzer (rack system).The initial result was 39.09 pg/ml.A new sample was obtained and the result was 10.34 pg/ml.The original and the new samples were repeated and the results were 10.86 pg/ml and 10.75 pg/ml, respectively.
Additional Manufacturer Narrative
It was provided that the patient had her blood collected on (b)(6) 2025, with normal routine tests, and her thyroglobulin was high (just over 26).The test was repeated at another laboratory after 15 days, as requested by the doctor, and the result showed thyroglobulin < 0.04, in line with previous test results.The customer site repeated the test on (b)(6) 2025, and the result was <0.04.Clarification regarding whether this information pertains to the alleged patient; however, no response has been received.Qc was within the acceptable range before sample measurement.A review of the provided preanalytical information showed that the serum clotting time was too short (10 min), which could lead to clots in the sample.The issue was determined to be due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.There is no product problem.

• Brand Name: ELECSYS TROPONIN T GEN 5
• Common Device Name: TROPONIN SUBUNIT IMMUNOASSAY METHOD
• 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: 23829591
• Report Number: 1823260-2025-05169
• Device Sequence Number: 9288642
• Product Code: MMI
• UDI-Device Identifier: 07613336158982
• UDI-Public: 07613336158982
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K201441
• 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): 01/19/2026

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: 08469890160
• Device Lot Number: 869586
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/19/2026
• 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