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

Catalog Number	08469890160
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial numbers are (b)(6).The field service engineer (fse) vacuumed dust particles, cleaned the filters, and wiper dust particles from the exhaust ducts from all three analyzers.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys troponin t gen 5 results for 4 patient samples on two cobas e 801 analytical units.The customer was prompted to repeat the samples as the initial results did not match the patients' clinical history.On (b)(6) 2026, sample 1 had an initial result of 52 ng/l on analyzer (b)(6).The repeat result was 31 ng/l.On (b)(6) 2026, sample 2 had an initial result of 19.2 ng/l on analyzer (b)(6) the repeat result was 8.99 ng/l.The sample was also repeated twice on analyzer (b)(6) and the results were 6.67 ng/l and <6.0 ng/l.On (b(6) 2026, sample 3 had an initial result of 18.6 ng/l on analyzer (b)(6) the repeat result from analyzer (b)(6) was 11.4 ng/l.On (b)(6) 2026, sample 4 had an initial result of 12.4 ng/l on analyzer (b)(6) the repeat result was 6.12 ng/l.The sample was repeated on analyzer (b)(6) and the result was <6.0 ng/l.The sample was also repeated on analyzer (b)(6) and the result was <6.0 ng/l.No questionable results were reported outside of the laboratory.

• 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: 24910467
• Report Number: 1823260-2026-01466
• Device Sequence Number: 9874226
• Product Code: MMI
• UDI-Device Identifier: 07613336158982
• UDI-Public: 07613336158982
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/29/2026

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: 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: 03/24/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/29/2026
• 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 Sex: Unknown