MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6802301
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	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that non-reproducible, higher than expected, vitros troponin i es (tropi es) results were obtained from four patient samples from four different patients when tested using vitros tropi es lot: 6110 on a vitros 5600 integrated system.A definitive assignable cause could not be determined.A review of qc fluid performance indicates acceptable performance, and a vitros tropi es lot: 6110 issue is not a likely contributor to the event.However, the customer does not process a control fluid with a troponin i concentration at, or below the url.Therefore, the performance of the vitros tropi es reagent lot: 6110 at, or below the url concentration of 0.034 ng/ml cannot be determined and a reagent issue could not be entirely ruled out as contributing to the event.Within run precision testing was not performed on the vitros 5600 integrated system, however acceptable historical vitros tropi es lot: 6110 qc indicates that an instrument issue is not a likely contributor to the event.Pre-analytical sample processing could not be ruled out as a contributing factor.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros product tropi es, lot: 6110.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report non-reproducible, higher than expected, vitros troponin i es (tropi es) results were obtained from four patient samples from four different patients when tested using vitros tropi es lot: 6110 on a vitros 5600 integrated system.Patient 1 result of 0.067 ng/ml (>url) versus the expected result of <0.012 ng/ml (ami) versus the expected result of <0.012 ng/ml (ami) versus the expected result of <0.012 ng/ml (ami) versus the expected result of <0.012 ng/ml (

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24046676
• Report Number: 3007111389-2026-00004
• Device Sequence Number: 9494824
• Product Code: MMI
• UDI-Device Identifier: 10758750002504
• UDI-Public: (01)10758750002504(17)260303(11)250410(10)6110
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: 03/03/2026
• Device Catalogue Number: 6802301
• Device Lot Number: 6110
• 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: 12/16/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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