MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTICS PRODUCTS HS TROPONIN 1 REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6912232
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	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, higher than expected troponin i results obtained from a patient sample when performing a comparison study using the vitros high sensitivity troponin i (hstni) reagent lot 0030 on a vitros xt 7600 integrated system.The results were considered discordant when compared to vitros tropes i es results obtained from the same patient samples.Patient 1 vitros hstni results of 42.40, 26.53 ng/l (>/= 12.00 ng/l 99th percentile url for males) vs.Vitros tropi es 0.020 ng/ml (
Additional Manufacturer Narrative
The investigation determined that discordant and higher than expected troponin i results were obtained from a patient sample when performing a comparison study using the vitros high sensitivity troponin i (hstni) reagent lot 0030 on a vitros xt 7600 integrated system.The results were considered discordant when compared to vitros tropes i es results obtained from the same patient sample.A definitive assignable cause of the event could not be determined based on the information provided.The ortho field application specialist (fas) was onsite performing correlation study of the vitros hstni assay which was not yet in use in the customer's laboratory.As part of the process, the ortho fas ensures that the vitros hstni assay is performing as intended on the vitros xt 7600 integrated system prior to the patient correlation study.Quality control (qc) results must be acceptable, or the fas would not progress with the validation.Therefore, it is not likely that an instrument or reagent issue contributed to this event.Pre-analytical sample processing could not be ruled out as a contributing factor, as it was not possible to determine whether the customer followed the sample collection device manufacturer recommendations for sample centrifugation.The data provided were generated as part of a correlation study conducted to support the laboratory introduction of a new assay, vitros high sensitivity troponin i (hstni).Results obtained using the vitros hstni assay were compared to results generated by the currently in use vitros troponin i es assay as part of routine verification activities.As vitros hstni is a highly sensitive assay, it is analytically designed to detect lower concentrations of troponin i than the existing assay and potentially enabling earlier detection of cardiac injury.Therefore, it is possible that results between the vitros hstni and tropi es assays will not always be concordant.A medical consult was conducted by the medical safety officer to assess the potential patient risk associated with a discordant vitros high sensitivity troponin i (hstni) result: patient 1 is a male patient diagnosed with a transient ischemic event and hypertension had vitros hstni results of 42.40 ng/l compared with vitros troponin i es results of 0.02 ng/ml.Although cardiac troponin may be elevated in patients with transient ischemic attack (tia), the degree of elevation is often below or near the 99th percentile url.An hstni result of 42.40 ng/l exceeds the 2023 esc recommended rule-in cutoff for possible acute myocardial injury.Considering that patients with tia may also experience thrombotic showers to the heart and other organs, a markedly elevated hstni result could prompt unnecessary invasive investigations, with the potential for serious patient injury.However, in this case, the elevated result was generated during a correlation study, was not reported outside of the laboratory, and there was no inappropriate physician intervention or report of patient harm.Thus, there is no risk of serious injury or serious deterioration in patient condition.If this issue were to recur under routine clinical conditions, there is a low probability that a falsely elevated hstni result of this magnitude could lead to unnecessary diagnostic or therapeutic interventions, such as cardiac angiography or treatment for acute myocardial infarction.While the likelihood of serious injury is considered remote, serious or long-term adverse outcomes are possible.Based on the above assessment, and in an abundance of caution, ortho clinical diagnostics has determined that this event is reportable.

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCTS HS TROPONIN 1 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: 24884880
• Report Number: 3007111389-2026-00076
• Device Sequence Number: 10494939
• Product Code: MMI
• UDI-Device Identifier: 10758750033522
• UDI-Public: (01)10758750033522(17)261006(11)260211(10)0030
• 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): 04/14/2026

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 Catalogue Number: 6912232
• Device Lot Number: 0030
• 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: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2026
• 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