MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6912232
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a discordant lower than expected troponin i result was obtained from a patient sample when tested using the vitros high sensitivity troponin i (hstni) reagent lot 0021 on a vitros 5600 integrated system.The result was considered discordant when compared to the non-vitros siemens method result for the same sample.Patient (male) m16 vitros hstni < 2.25 ng/l (<12 ng/l, upper reference limit (url) cutoff) vs.Expected positive result of 144.7 ng/l ( > 76.0 ng/l, non-vitros siemens method url cutoff) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower-than-expected vitros hstni result was not reported from the laboratory.The data provided was generated as part of a correlation study conducted to support the laboratory introduction of a new assay, vitros high sensitivity troponin i (hstni).There were no allegations 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 determined that a discordant lower than expected troponin i result was obtained from a patient sample when tested using the vitros high sensitivity troponin i (hstni) reagent lot 0021 on a vitros 5600 integrated system.The result was considered discordant when compared to the non-vitros siemens method result for the same sample.An assignable cause for the discordant lower than expected patient sample result could not be determined.Based on the ortho field application specialist (fas)s acceptable quality control (qc) and calibrator fluid results, a vitros hstni lot 0021 performance issue is not a likely contributor to the event.Based on the ortho fass acceptable within run precision study, an instrument related issue is not a likely contributor to the event.Continual track and trending has identified an increase in vitros hstni us complaints.Further investigation of vitros hstni lot 0021 will be documented in (b)(4).Pre-analytical sample processing could not be ruled out as a contributing factor, as the customer was not following the sample collection device manufactures recommendation for sample centrifugation.As a result, improper pre-analytical sample handling may have contributed to the event.Additionally, it is possible that an interferent affecting the vitros hstni method but not the non-vitros siemens method contributed to the lower than expected patient sample result.The vitros hstni instructions for use (ifu) states: "dextran at therapeutic doses significantly interferes with this test.Heterophile as well as human anti-animal antibodies (most common human anti-mouse antibodies or hama) in serum or plasma of certain individuals are known to cause interference with immunoassays." however, the customer did not perform any interference testing on the patient samples.Consequently, an interferent that impacts the vitros hstni method but not the non-vitros siemens method cannot be ruled out as a contributing factor to the event.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I 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: 24912706
• Report Number: 3007111389-2026-00082
• Device Sequence Number: 18623986
• Product Code: MMI
• UDI-Device Identifier: 10758750033522
• UDI-Public: (01)10758750033522(17)261001(11)260206(10)0021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 10/01/2026
• Device Catalogue Number: 6912232
• Device Lot Number: 0021
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2026
• 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