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 Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that report higher than expected troponin es results obtained from a single patient sample using vitros troponin i es (tropi es) reagent lot 6070 on a vitros 5600 integrated system.The results were considered discordant when compared to a vitros hs troponin i (hstni) result and a non-vitros troponin result obtained from the same patient sample.The assignable cause of the non-reproducible higher than expected patient sample result could not be determined.Based on historical qc fluid results, a vitros tropi es lot 6070 performance 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 6011 at or below the url concentration of 0.034 ng/ml cannot be determined, and a reagent issue cannot be entirely ruled out as a contributing factor to the event.The customer did not perform a precision test; therefore, instrument performance at the time of the event could not be verified.However, there was no evidence indicating an instrument related issue.Pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturers recommended centrifugation protocol.Improper pre-analytical sample handling may have contributed to the event.It is possible that cellular debris resulting from inadequate sample preparation was present in the affected sample; however, this could not be confirmed.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tropi es reagent lot 6070.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected troponin es results were obtained from a single patient sample using vitros troponin i es (tropi es) reagent lot 6070 on a vitros 5600 integrated system.The results were considered discordant when compared to a vitros hs troponin i (hstni) result and a non-vitros troponin result obtained from the same patient sample.Patient 1, sample 1 vitros tropi es results of 0.256 and 0.26 ng/ml which is > ami cutoff 0.120 ng/ml versus the expected result hstni result of

• 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: 23863423
• Report Number: 3007111389-2025-00140
• Device Sequence Number: 9409596
• Product Code: MMI
• UDI-Device Identifier: 10758750002504
• UDI-Public: (01)10758750002504(17)260104(11)250303(10)6070
• 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): 12/19/2025

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: 01/04/2026
• Device Catalogue Number: 6802301
• Device Lot Number: 6070
• 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: 12/06/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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