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

Catalog Number	08469865160
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
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 result of a baseline patient sample at 4:00 pm was 226 ng/l.The initial result from the analyzer of the next timed patient sample at 6:00 pm was 28 ng/l.The repeat result from another e411 analyzer of the next timed patient sample at 6:11 pm was 229 ng/l.The next timed patient sample's initial result was not reported outside the laboratory as it did not match the patient's clinical picture, prompting the rerun.The repeat result was deemed correct and reported.
Additional Manufacturer Narrative
The cobas e411 rack serial number is (b)(6).The calibration results were acceptable.The alarm trace contained a clot pipetting error.The field service engineer inspected the analyzer but could not determine the event's cause.He performed adjustments on the sample, reagent, and sipper probes.He verified the analyzer's performance by successful precision checks; the customer performed successful qcs.The investigation is ongoing.
Additional Manufacturer Narrative
In the initial medwatch, h11 additional narrative should have been: "the cobas e411 rack serial number is (b)(6).The alarm trace contained a clot pipetting error.The field service engineer inspected the analyzer but could not determine the event's cause.He performed adjustments on the sample, reagent, and sipper probes.He verified the analyzer's performance by successful precision checks; the customer performed successful calibration and qcs.The investigation is ongoing." instead of: "the cobas e411 rack serial number is (b)(6).The calibration results were acceptable.The alarm trace contained a clot pipetting error.The field service engineer inspected the analyzer but could not determine the event's cause.He performed adjustments on the sample, reagent, and sipper probes.He verified the analyzer's performance by successful precision checks; the customer performed successful qcs.The investigation is ongoing." the customer did not report any other issues after the service.The investigation determined that the service actions resolved the issue.

• 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: 22069491
• Report Number: 1823260-2025-01576
• Device Sequence Number: 8703233
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 07/08/2025

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: 82721401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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: 81 YR
• Patient Sex: Female