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

Model Number	TNT G5 STAT
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys troponin t gen.5 stat assay on a cobas e 411 immunoassay analyzer.The patient sample initially resulted in a troponin t value of 17.47 ng/l and this value was reported outside of the laboratory.The result was questioned as it did not match the patient's history.The sample was repeated, resulting in a value of 692.6 ng/l.The repeat value was deemed correct and matched the patient's history.The tropinin t reagent lot number was 63006301, with an expiration date of 31-oct-2023.
Additional Manufacturer Narrative
The field service engineer inspected the system and did not find a root cause.He performed a high-voltage adjustment of the photomultiplier tube.Performance testing, calibration, and controls were run.
Additional Manufacturer Narrative
There were no alarms on the last calibration performed on (b)(6) 2023.Quality controls were within range.There was no indication of a reagent or instrument performance issue.The sample centrifugation time may have been shorter and the speed may have been higher than recommended by the tube manufacturer.Upon review of the alarm trace, no relevant alarms were observed.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16296468
• Report Number: 1823260-2023-00345
• Device Sequence Number: 14857072
• Product Code: MMI
• UDI-Device Identifier: 04015630942695
• UDI-Public: 04015630942695
• Combination Product (Y/N): N
• 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): 04/10/2023
• 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: 10/31/2023
• Device Model Number: TNT G5 STAT
• Device Catalogue Number: 07398000160
• Device Lot Number: 63006301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 79 YR
• Patient Sex: Female