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	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a non-reproducible, higher than expected vitros troponin i es (tropi es) result was obtained from a single patient sample when tested on a vitros xt 7600 integrated system.The result was non-reproducible, higher than expected when compared to the repeat vitros tropi es result observed from the same patient sample.A definitive assignable cause could not be determined.A review of qc fluid results indicates acceptable reagent 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.No precision testing was performed on the vitros xt 7600 system to verify instrument performance.However, there was no indication of an instrument malfunction and qc results were well within expectations.Additionally, an acceptable repeat result was obtained for the affected patient sample without any known actions being performed on the system.Therefore, an instrument related issue is not a likely contributor to the event.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 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 a non-reproducible, higher than expected vitros troponin i es (tropi es) result was obtained from a single patient sample when tested on a vitros xt 7600 integrated system.The result was non-reproducible, higher than expected when compared to the repeat vitros tropi es result observed from the same patient sample.Patient sample 1 result of 0.733 ng/ml (above the ami cutoff) versus the repeat result of < 0.012 ng/ml 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 and questioned by a physician.A corrected report was later issued for the affected sample.No treatment was initiated, altered or stopped based on the initial reported tropi es result and 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 613066.

• 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: 24026829
• Report Number: 3007111389-2026-00002
• Device Sequence Number: 18779108
• 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): 01/09/2026

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: 12/15/2025
• Initial Report FDA Received Date: 01/09/2026
• 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