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	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined a discordant, higher than expected result when comparing a vitros immunodiagnostics products hs troponin i (hstni) result obtained from a patient sample to the result obtained using vitros troponin i reagent on a vitros xt7600 integrated system.A consultation with a quidelortho medical safety officer concluded this result is reportable as indicated by the following: most clinical guidelines advise caution when interpreting isolated troponin elevations in critically ill patients, as troponin testing lacks specificity for type 1 mi in this population.Additionally, the vitros hstni results were obtained during a correlation study, were not reported outside the laboratory, and there were no allegations of patient harm.In this case, the risk of serious patient injury is considered unlikely.However, given that the result exceeds five times the male 99th percentile url (12 ng/l) and the 40 ng/l rule-in cut-off vitros hstni, there is a possibility that, under unusual circumstances, such a result could lead to escalated invasive investigations with the potential for serious patient injury.The assignable cause of the higher than expected vitros hstni result could not be determined.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 high 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.The ortho field application specialist (fas) was onsite performing validation of the vitros hstni assay which was not yet in use in the customers laboratory.As part of the validation process, the ortho fas ensures that the vitros hstni assay is performing as intended on the vitros xt7600 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 issue with the vitros xt7600 analyzer contributed to the event.As this testing was performed for introduction of a new assay, there was no historical quality control (qc) for review of the vitros hstni reagent lot 0021 performance.Continual track and trending has identified an increase in vitros hstni us complaints.The sample type was plasma and fas has confirmed samples were not hemolyzed, icteric or turbid.The date the sample was collected was not provided, however, the quidelortho fas stated all samples were collected and tested with the vitros tropi es assay 2 to 6 days prior to testing with the vitros hstni us assay on 18 march 2026.The sample was processed for the vitros tropi es assay on the vitros xt7600 integrated system and immediately placed in freezer until correlation study performed by quidelortho fas.No details were provided on preanalytical handing on the sample at initial draw and after sample was thawed and processed for correlation.Therefore, pre-analytical sample handling could have contributed to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a discordant, higher than expected result when comparing a vitros immunodiagnostics products hs troponin i (hstni) result obtained from a patient sample to the result obtained using vitros troponin i reagent on a vitros xt7600 integrated system.Vitros hstni = 278.1 ng/ml (>male 99th percentile url) versus tropi es = 0.020 ng/ml (

• 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: 24971467
• Report Number: 3007111389-2026-00086
• Device Sequence Number: 18755977
• Product Code: MMI
• UDI-Device Identifier: 10758750033522
• UDI-Public: (01)10758750033522(17)260903(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): 04/22/2026

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: 09/03/2026
• 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: 03/26/2026
• Initial Report FDA Received Date: 04/23/2026
• 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