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	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected troponin i es (tropi es) result was obtained when a single patient sample was tested using vitros tropi es lot: 6220 on a vitros 5600 integrated system.Patient 1 result of 0.183 ng/ml versus the expected result of 0.025 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 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).
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected troponin i es (tropi es) result was obtained when a single patient sample was tested using vitros tropi es lot: 6220 on a vitros 5600 integrated system.A definitive assignable cause could not be determined.There were no suggestions of qc issues from vitros tropi es lot: 6220 testing by the customer and ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros product tropi es, lot: 6220.However, it was not possible to establish whether the customer processed a qc with a troponin i concentration at, or below the url.Therefore, the performance of the vitros tropi es reagent lot: 6220 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 conducted when requested.However, the customer gave no indication of any vitros 5600 system malfunction and the customer made no suggestion of any issues with the qc fluids processed on the instrument at the customer site.Therefore, an instrument issue is not a likely contributor to the event.The manufacturer of the collection device the higher than expected vitros tropi es result was obtained was not provided when requested.Therefore, it was not possible to determine whether the customer was following the sample collection device manufactures recommendation for sample centrifugation.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.The patient sample had a hemolysis index of 49 when the vitros tropi es result of 0.183 ng/ml was obtained.A non-hemolyzed sample is expected to return a hemolysis index of 15, therefore, hemolysis in the patient sample is a possible contributor to the event.

• 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: 24369681
• Report Number: 3007111389-2026-00034
• Device Sequence Number: 9781806
• Product Code: MMI
• UDI-Device Identifier: 10758750002504
• UDI-Public: (01)10758750002504(17)260602(11)250730(10)6220
• 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): 02/17/2026

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: 06/02/2026
• Device Catalogue Number: 6802301
• Device Lot Number: 6220
• 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: 01/20/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• 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