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

Model Number	E601
Medical Device Problem Codes	Incorrect Measurement (1383); High Readings (2459); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The troponin t reagent lot number was 827214.The reagent expiration date was requested, but not provided.The field service engineer ran performance testing on the instrument and this passed.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they receive questionable results for an unspecified number of patient samples tested with elecsys troponin t gen 5 stat on a cobas 6000 e601 module.The customer provided an example of one patient sample with discrepant troponin t results.The customer noticed issues with quality control recovery, so they pulled previously tested patient samples and repeated these on a second analyzer.No questionable results were reported outside of the laboratory.The repeat results were deemed correct.The sample initially resulted in a troponin t value of 11.8 ng/l and it repeated as 20.0 ng/l.
Additional Manufacturer Narrative
The last reagent pack calibration performed on (b)(6) 2025, was successful.The customer stated that quality controls were mishandled by staff and that the staff member has been trained on correct handling.The customer has not reported any further issues.The investigation determined the issue was consistent with the customer's mishandling of control material.Medwatch field d1, d2, d4, g1, and g4 updated.

• 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: 23028569
• Report Number: 1823260-2025-02842
• Device Sequence Number: 9819951
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/17/2025

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 Model Number: E601
• Device Catalogue Number: 08469865160
• Device Lot Number: 827214
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/17/2025
• 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 Sex: Unknown