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

Catalog Number	08469865160
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
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 e411 disk.The sample initially resulted in a troponin t value of 62 ng/ml.The provider requested a repeat of the sample.The sample was repeated, resulting in a troponin t value of < 6 ng/ml.The repeat value was deemed correct and agreed with the patient's history.
Additional Manufacturer Narrative
The serial number of the e411 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
For the calibration performed on 03-apr-2024, the first level calibrator signal was ok and the second level signal was slightly lower than expected.Quality controls were acceptable.There was no indication of a reagent performance issue.Upon review of the alarm trace, no relevant alarms were observed.The field service engineer could not determine a cause.The probes were checked.Mixer and probe adjustments were checked and were acceptable.A system volume check was performed and passed.Performance testing passed.The investigation could not identify a product problem.The 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: 19145388
• Report Number: 1823260-2024-01216
• Device Sequence Number: 7443758
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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): 06/14/2024

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 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): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/14/2024
• 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 Age: 50 YR
• Patient Sex: Male