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); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The field service engineer inspected the analyzer, performed diagnostics, and determined that there were no mechanical or fluidic issues.He attributed the event to sample quality issues.He performed a manual wipe-down of the shaft for temperature regulation to remove accumulated dust and ensure thermal stability, replaced the sipper syringe assembly, reviewed the analyzer's photos associated with the event, and verified the analyzer's performance with comprehensive instrument checks and camera log audit.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys troponin t gen 5 result from one patient sample tested on the cobas e 801 analytical unit.The initial result from the analyzer was 23.9 ng/l.The repeat result from the analyzer was 11.7 ng/l.The repeat result from another cobas analyzer was 11.4 ng/l.The physician questioned the initial result as it did not match the patient's first result of 12.5 ng/l, prompting the rerun.The patient's third result after two hours was 12.0 ng/l.The repeat results were deemed correct.
Additional Manufacturer Narrative
The investigation reviewed the data set provided by the customer: the calibration results are within the specified ranges.The qc results are within the specified ranges.There is no indication of a performance issue with the reagent.The preanalytical data do not indicate any issues.The cause of the event could not be determined.The investigation determined that the service actions resolved the issue.

• 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: 24910472
• Report Number: 1823260-2026-01470
• Device Sequence Number: 9874229
• Product Code: MMI
• UDI-Device Identifier: 07613336158982
• UDI-Public: 07613336158982
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 05/28/2026

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: 88249601
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/28/2026
• 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 Age: 67 YR
• Patient Sex: Male