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

Catalog Number	08469865160
Medical Device Problem Codes	Low Test Results (2458); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The troponin t gen 5 stat reagent expiration date was not provided.The cobas e411 disk serial number was (b)(6).The qc was acceptable.The field service engineer (fse) checked the analyzer and found no cause for the event, but discovered that the sample disk had broken tabs.He replaced the sample disk and checked the sample, reagent, and sipper probe adjustments, the pressure sensor, and the sipper voltage.Precision studies were performed, and they were within specifications.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with elecsys troponin t gen 5 stat assay on a cobas e 411 analyzer (disk system).Sample 1: initial result: 9.7 ng/l.Repeat result: 18.4 ng/l.Sample 2: initial result: 15.8 ng/l.Repeat results: 65.1 ng/l and 64.7 ng/l.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The visual check of the samples showed no abnormalities.A general reagent or analyzer problem can be excluded since the qc prior to the event was within the ranges.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TROPONIN T GEN 5 STAT
• 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: 24730967
• Report Number: 1823260-2026-01161
• Device Sequence Number: 10191660
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: 08469865160
• Device Lot Number: 869594
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/06/2026
• 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