MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T STAT ASSAY; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number	07398000160
Medical Device Problem Codes	Incorrect Measurement (1383); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number and expiration date were not provided.The qc recovery data provided was acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys troponin t stat assay results for 1 patient sample on a cobas e 411 immunoassay analyzer.The initial troponin result was 13.64 pg/ml.The patient had subsequent samples collected that gave results around 750 pg/ml which prompted the doctor to question the initial result.The initial sample was repeated and the repeat result was 680 pg/ml.The repeat result was deemed correct.
Additional Manufacturer Narrative
The field service engineer (fse) inspected the instrument and lubricated all rails and bearings.The fse performed a precision check successfully.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS TROPONIN T STAT ASSAY
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• 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: 18696497
• Report Number: 1823260-2024-00418
• Device Sequence Number: 20875415
• Product Code: MMI
• UDI-Device Identifier: 04015630942695
• UDI-Public: 04015630942695
• Combination Product (Y/N): Y
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K051752
• 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): 03/01/2024
• 2 Devices were Involved in the Event: 1 2

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: 07398000160
• Device Lot Number: ASKU
• 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: 01/21/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/01/2024
• 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