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	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable high elecsys troponin t gen 5 result from the cobas e 801 analytical unit for one patient.There were three samples collected.The first sample result was 8 ng/l.The questionable results were on the second sample: the initial result for the second sample was 18 ng/l, and the repeat result was 9 ng/l.The sample was repeated after the doctor questioned the initial results.The third sample result was 8 ng/l.The lower results were believed to be correct.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).A field service engineer (fse) performed a liquid flow path cleaning, cleaned the sipper flow for the sippers, checked all adjustments, and flushed the sippers' syringes.For verification, the fse ran a precision check for troponin t, which passed.The investigation is ongoing.
Additional Manufacturer Narrative
Qc was acceptable.No relevant instrument alarms occurred.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 24608105
• Report Number: 1823260-2026-00926
• Device Sequence Number: 15911122
• Product Code: MMI
• UDI-Device Identifier: 07613336158982
• UDI-Public: 07613336158982
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/13/2026

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: 882496
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/13/2026
• 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: 42 YR
• Patient Sex: Female