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

Catalog Number	08469865160
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys troponin t gen 5 stat assay (troponin t stat) on a cobas e 411 analyzer (rack system).The initial result was 152.6 ng/l with a data flag.The nurse questioned this result and repeat testing was performed.The repeat from a different e411 analyzer was 31.28 ng/l.The repeat from the e411 analyzer in question was 31.60 ng/l with a data flag.The repeat results were believed to be correct.
Additional Manufacturer Narrative
The e411 analyzer serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on 16-jan-2024; the calibration signals were lower than expected.The customer stated qc was acceptable.No pre-analytical issues were identified.No issues were identified during a review of the alarm trace data.The field service engineer (fse) did not find a cause for the event.The instrument was checked.Instrument performance and precision tests passed.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TROPONIN T GEN 5 STAT ASSAY
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21354309
• Report Number: 1823260-2025-00389
• Device Sequence Number: 18423680
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K162895
• 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): 03/07/2025

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: 06/30/2025
• Device Catalogue Number: 08469865160
• Device Lot Number: 77198501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/07/2025
• 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: 45 YR
• Patient Sex: Female