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	02/03/2026
Type of Reportable Event	Malfunction
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 repeat of the sample from the same patient.A definitive assignable cause of the event could not be determined with the information provided.Based on historical qc fluid results, a vitros tropi es lot 6220 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 6220 at, or below the url concentration of 0.034 ng/ml could not be determined and a reagent issue could not be entirely ruled out as contributing to the event.Within run precision testing was not performed on the instrument upon request, consequently, no assessment of the instrument performance at the time of the event was made.Therefore, it cannot be confirmed that the instrument was operating as intended and unexpected instrument performance cannot be completely ruled out as contributing to the event.However, historical vitros qc fluid results were within expectations, and no evidence of instrument malfunction was reported.Therefore, an instrument issue is an unlikely cause of the event.Pre-analytical sample processing could not be ruled out as a contributing factor, as it was not determined if the customer was following the sample collection device manufactures recommendation for sample centrifugation.Therefore, improper pre-analytical sample handling could be a contributor to this event.Continual tracking and trending of complaint data has not identified any signals that would lead to a potential systemic quality issue with vitros tropi es reagent lot 6220.
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 repeat of the sample from the same patient.Patient 1 vitros tropi es result of 0.110 ng/ml versus the expected 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 of 0.110 ng/ml was not reported from the laboratory.There has been 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: 24489844
• Report Number: 3007111389-2026-00040
• Device Sequence Number: 5003653
• 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): 03/02/2026

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: 02/03/2026
• Initial Report FDA Received Date: 03/02/2026
• 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