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

Catalog Number	08469865160
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The troponin t stat reagent lot number was 743112 with an expiration date of 31-jan-2025.The customer received various error codes related to sample probe and sipper probe movement.The questionable results were accompanied by an "auxiliary reagent short" data flag.Qc was acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned the results for 5 patient samples tested for elecsys troponin t gen 5 stat assay (troponin t stat) on a cobas e 601 module.The customer provided an example of discrepant results for 1 patient sample.The initial result was approximately 25 ng/ml with a data flag.Due to the data flag, the sample was repeated on a different e601 module with a result of approximately 50 ng/ml.The repeat result was believed to be correct.
Additional Manufacturer Narrative
Section d, device identification was updated.Relevant fields of sections d and g were updated.The e601 module serial number was (b)(6).Calibration was last performed on (b)(6) 2024 with acceptable results.Qc was acceptable.There is no indication of a reagent or instrument performance issue.An "abnormal probe sucking" alarm was observed on the alarm trace data.This alarm is an indication of possible poor sample quality.The field service engineer (fse) did not identify a cause for the event.The fse adjusted the main pump pressure and verified multiple parts of the instrument which were all either in range or working correctly.A system purge and prime, precision checks, and qc were all acceptable.Based on the data provided, a specific root cause could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS TROPONIN T GEN 5 STAT ASSAY
• 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: 19655974
• Report Number: 1823260-2024-01919
• Device Sequence Number: 20489030
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162895
• 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): 08/14/2024
• 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 Expiration Date: 01/31/2025
• Device Catalogue Number: 08469865160
• Device Lot Number: 743112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/14/2024
• 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