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

Model Number	E 411
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The last calibration was performed on 30-may-2025.Quality controls were acceptable.A review of alarm trace data showed no relevant alarms.The field service engineer determined there was a bad calibration of troponin t.Troponin t results normalized after re-calibration.The investigation could not identify a product problem.It was determined that the re-calibration resolved the issue.Medwatch fields d1, d2, d4, g1, and g4 have been updated.
Additional Manufacturer Narrative
The troponin t reagent lot number was 82721400, with an expiration date of 30-apr-2026.The customer ran water as patient samples on the complained analyzer and the troponin t results were around 37 to 38 ng/l versus approximately 10 ng/l when tested in a second analyzer.The customer replaced the reagent pack and re-calibrated.It was noted that the baseline calibration signals were raised.The customer tried running water as a patient sample again and this time it recovered within expectations.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys troponin t gen 5 stat on a cobas e 411 analyzer.The sample initially resulted in a troponin t value of approximately 35 ng/l.Another sample collected from the patient resulted in a troponin t value of < 6 ng/l, so the result from the complained sample was questioned.The complained sample was repeated on a second analyzer on (b)(6) 2025, resulting in a troponin t value of < 6 ng/l with a data flag.The customer repeated the sample on the original e411 analyzer and it resulted in a value of 39.8 ng/l.The < 6 ng/l value from the second analyzer was deemed correct.

• 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 46250-0457
• MDR Report Key: 22296733
• Report Number: 1823260-2025-01891
• Device Sequence Number: 18222488
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 06/25/2025

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: 04/30/2026
• Device Model Number: E 411
• Device Catalogue Number: 08469865160
• Device Lot Number: 82721400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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 Age: 49 YR
• Patient Sex: Female