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	06/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).Calibration was last performed on (b)(6) 2024.The customer stated that their calibration and qc recovery data was acceptable.The field service engineer (fse) verified analyzer operation and performed a mechanical test successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys troponin t stat assay results for 1 patient serum sample on a cobas 8000 - cobas e 602 module.The initial troponin result was 7 ng/l.The customer was prompted to repeat the sample as the initial result was accompanied by two analyzer alarms.The sample was repeated on another analyzer and the result was 22 ng/l.No questionable results were reported outside of the laboratory.The repeat result was deemed correct.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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
• MDR Report Key: 19701630
• Report Number: 1823260-2024-01965
• Device Sequence Number: 7655624
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 08/05/2024

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: 01/31/2025
• Device Catalogue Number: 08469865160
• Device Lot Number: 74311200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/05/2024
• 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