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

Model Number	E801
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	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's sample tested with elecsys troponin t gen5 assay on a cobas e 801 analytical unit.Initial result: 215 ng/l (tested on measuring cell 1).The initial result was high, prompting the repeat of the sample per the customer's standard operating procedure for critically high troponin values.Repeat result: 25.9 ng/l (tested on measuring cell 2).The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The troponin t gen5 reagent lot number was 847378.The expiration date was not provided.The qc was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
Although sample quality alarms were observed 7 times on the date of the event, the sample was checked, and it showed no quality issues.The sample foam detection (sfd) images were reviewed, and no sample-quality image was observed for the sample.The customer and service maintenance were complete per the specifications.The instrument was cleaned daily.The field service engineer verified the sample probe adjustments and the active gripper.Precision studies were performed, and they were within specifications.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
• 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: 24701981
• Report Number: 1823260-2026-01111
• Device Sequence Number: 15979931
• 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): 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 Model Number: E801
• Device Catalogue Number: 08469890160
• Device Lot Number: 847378
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/26/2026
• 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 Age: 57 YR
• Patient Sex: Female