MAUDE Adverse Event Report: Roche Diagnostics Elecsys Troponin T Gen 5; Troponin Subunit Immunoassay Method

Catalog Number	08469890160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys troponin t gen 5 assay on a cobas e 801 analytical unit.The initial result was 309 ng/l.Since the patient did not have any cardiac symptoms, the physician questioned the initial result and requested a repeat of the sample.The sample was repeated on the same e 801, and the 1st repeat result was <6 ng/l (accompanied by a data flag).This result was not reported outside the laboratory.The sample was then retested on a different instrument, and the 2nd repeat result was <6 ng/l (accompanied by a data flag).The repeat results were deemed to be correct.The 2nd repeat result was reported outside the laboratory.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The qc was acceptable.The visual inspection of the sample showed no abnormalities.The investigation is ongoing.

• 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 -045
• 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: 50865755
• Report Number: 1823260-2026-03898
• Device Sequence Number: 16131225
• Product Code: MMI
• UDI-Device Identifier: 07613336158982
• UDI-Public: 07613336158982
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 912845
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• 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