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	01/21/2026
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 es result was obtained from a single patient sample using vitros troponin i es (tropi es) reagent lot 6220 on a vitros 5600 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 0.067 ng/ml (above the upper reference interval) versus the expected vitros hstni result of <1.5 ng/l (below the acute myocardial infarction cutoff of 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 of 0.067 ng/ml 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).
Additional Manufacturer Narrative
The investigation has determined that a non-reproducible higher than expected troponin es result was obtained from a single patient sample using vitros troponin i es (tropi es) reagent lot 6220 on a vitros 5600 integrated system.The result was considered discordant when compared to a vitros hs troponin i (hstni) result obtained from the same patient sample.The assignable cause of the non-reproducible higher than expected patient sample result could not be determined.It is unknown which qc material the customer uses to verify the performance of the vitros tropi es reagent.In addition, no quality control data was provided, therefore, it was not possible to assess the performance of vitros tropi es reagent lot 6220 at the time of the event.Consequently, a reagent-related issue cannot be ruled out as a contributing factor to the event.No precision testing was performed on the vitros 5600 integrated system; therefore, instrument performance at the time of the event could not be verified.However, there was no evidence of an instrument malfunction as an acceptable result for the patient was obtained on the vitros 5600 system using the vitros hstni assay.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.The customer used a blocking tube when repeating the patients sample using vitros tropi es and obtained a result of 0.045 ng/ml.The type of blocking tube used was not provided.The result obtained using the unknown blocking tube was lower than the initial result of 0.067 ng/ml, indicating a possible unknown interferent that affects the tropi es reagent but not the vitros hstni reagent as a potential contributor to the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tropi es reagent lot 6220.

• 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: 24380937
• Report Number: 3007111389-2026-00035
• Device Sequence Number: 18694168
• 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): 02/18/2026

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: 01/22/2026
• Initial Report FDA Received Date: 02/18/2026
• 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