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	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a discordant, higher expected troponin i es (tropi es) result was obtained from a single patient sample when tested using vitros tropi es reagent lot 6240 on a vitros 5600 integrated system.The result was considered discordant when compared to non-vitros troponin i results for the same patient sample.A definitive assignable cause could not be determined.Reported qc fluid performance indicates a vitros tropi es lot 6240 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 6240 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 instrument, so it was not possible to verify the performance of the instrument at the time of the event.Therefore, an instrument issue cannot be completely ruled out as contributing to the event, although, there is no evidence or any suggestion from the customer that the instrument was not performing as intended.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was not possible to establish whether the customer was following the sample collection device manufactures recommendation for sample centrifugation and cellular debris, due to poor sample preparation, could be 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 6240.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a discordant, higher expected troponin i es (tropi es) result was obtained from a single patient sample when tested using vitros tropi es reagent lot 6240 on a vitros 5600 integrated system.The result was considered discordant when compared to non-vitros troponin i results for the same patient sample.Patient 1 result of 0.3 ng/ml (above the ami) versus non-vitros troponin i results below the ami biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, higher than expected vitros tropi es result was not reported from the laboratory.There was no 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).

• 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: 25160057
• Report Number: 3007111389-2026-00097
• Device Sequence Number: 8771716
• Product Code: MMI
• UDI-Device Identifier: 10758750002504
• UDI-Public: (01)10758750002504(17)260604(11)250801(10)6240
• 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): 05/13/2026

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: 06/04/2026
• Device Catalogue Number: 6802301
• Device Lot Number: 6240
• 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: 04/17/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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