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	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected troponin es result was obtained from a single patient sample using vitros troponin i es (tropi es) reagent lot 6110 on a vitros xt 7600 integrated system.The result was considered discordant when compared to a vitros hs troponin i (hstni) result obtained from the same patient sample.Patient 1 vitros tropi es result of 0.107 ng/ml (above the upper reference interval) versus the expected result of <1.5 ng/l.A vitros hstni result of <1.5 ng/l (below the cutoff for determination of acute myocardial infarction) cutoff 11 ng/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible higher than expected vitros tropi es result was reported from the laboratory.A physician questioned the result, and no treatment was initiated, altered, or stopped based on the reported result and a corrected report of <1.5 ng/l (vitros hstni) was later issued for the patient.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation has determined that a higher than expected troponin es result was obtained from a single patient sample using vitros troponin i es (tropi es) reagent lot 6110 on a vitros xt 7600 integrated system.The result was considered discordant when compared to a vitros hs troponin i (hstni) result obtained from the same patient sample.A definitive assignable cause could not be determined.Based on historical qc fluid results, a vitros tropi es lot 6110 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 6110 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 on the analyzer; 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 it is unknown if the customer was following the sample collection device manufacturers recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.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 indicate a potential systematic issue with vitros tropi es reagent lot 6110.

• 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: 24278461
• Report Number: 3007111389-2026-00027
• Device Sequence Number: 8289712
• Product Code: MMI
• UDI-Device Identifier: 10758750002504
• UDI-Public: (01)10758750002504(17)260330(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): 02/04/2026

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: 03/30/2026
• 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: 01/12/2026
• Initial Report FDA Received Date: 02/06/2026
• 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