MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T GEN 5 STAT; 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	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e601 module serial number was (b)(6).The field service engineer (fse) performed preventive maintenance on the e601 module in question.Afterward, the customer repeated the sample, and the result was 7.0 ng/l.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant high results for 1 patient tested for elecsys troponin t gen 5 stat (troponin t stat) on a cobas 6000 e601 module.The initial result was 24 ng/l from the e601 module in question.The physician questioned the result due to the patient's age.The sample was repeated on the e601 module in question, with a result of 24 ng/l.The customer repeated the sample on a different e601 in the laboratory, and the result was 6 ng/l.The sample was repeated on this 2nd module, and the result was again "within the normal range." the actual result was not provided.The result of 6 ng/l was believed to be correct, and the result was amended in the patient¿s chart.The customer replaced the reagent packs on both modules and performed calibration and qc.The sample was repeated on both modules, and the result was "elevated" on the e601 module in question and "normal" on the 2nd e601 module.The actual results were not provided.
Additional Manufacturer Narrative
Calibration and qc were acceptable.No relevant alarms were observed on the alarm trace data.The field service engineer (fse) did not find a cause for the event.The fse checked the probe alignments, replaced syringe seals, checked the gear pump pressure, and the measuring cells.Calibration and qc were acceptable.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
• 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: 22087045
• Report Number: 1823260-2025-01604
• Device Sequence Number: 6907127
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/05/2025

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 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): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/05/2025
• 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: 23 YR
• Patient Sex: Male