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

Model Number	E801
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
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 assay on a cobas e 801 analytical unit.The sample initially resulted in a troponin t value of 18 ng/l and this value was reported outside of the laboratory.A doctor questioned the result, so the sample was repeated, resulting in a value of 5 ng/l.The repeat value was deemed correct.The troponin t reagent lot number and expiration date were requested, but not provided.
Additional Manufacturer Narrative
The field service engineer ran an instrument check.The customer calibrated and ran controls.No further issues were reported.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: TROPONIN T
• 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: 16657503
• Report Number: 1823260-2023-01036
• Device Sequence Number: 1687267
• Product Code: MMI
• UDI-Device Identifier: 04015630920938
• UDI-Public: 04015630920938
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961500
• 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): 05/08/2023
• 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 Model Number: E801
• Device Catalogue Number: 04491815190
• Device Lot Number: ASKU
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/08/2023
• 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 Sex: Unknown