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

Catalog Number	08469865160
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable elecsys troponin t g5 stat result from one patient sample tested on the cobas e411 rack.The initial result was 17.69 ng/l.The repeat result was 1248 ng/l.The initial result was not reported outside the laboratory as it was deemed low and did not match the patient's history, prompting the rerun.
Additional Manufacturer Narrative
The reagent lot number and expiration date were requested but not provided.The field service engineer inspected the analyzer but could not determine what caused the event.He noted that the customer was using cups that were not recommended for use on the analyzer.He performed all the required checks and made minor adjustments to the sample/reagent probe and the buffer bottom position.He performed an unsuccessful mechanical check.He then replaced the measuring cells and verified the analyzer's performance with mechanical checks, calibration, qc, and precision checks.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) updated.The calibration results were within the specified ranges.The qc results were within the specified ranges.The alarm trace had a sample liquid level detection (lld) noise error.This is an indicator of possible poor sample quality.Multiple sample lld malfunctions during movement errors were also noted.A general reagent or analyzer problem was not detected because the qc before the event was within the specified ranges.The investigation did not identify a product problem based on the information provided.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: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 21708409
• Report Number: 1823260-2025-00911
• Device Sequence Number: 14651875
• 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: 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): 05/05/2025

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: 10/31/2025
• Device Catalogue Number: 08469865160
• Device Lot Number: 80225301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/05/2025
• 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: 78 YR
• Patient Sex: Female