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

Catalog Number	6912232
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2026
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 vitros hstni results were obtained from a single patient sample when tested using vitros immunodiagnostic products hs troponin i (hstni) reagent pack lot: 1510 on a vitros 5600 integrated system.The results were higher than expected when compared to a non-vitros beckman highly sensitive troponin i result below the upper reference interval (url).Neither the beckman result or url were provided.Patient sample vitros hstni results of 550.0, 568.6 and 513.1 ng/l versus a beckman highly sensitive troponin i result below the upper reference interval (url).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher-than-expected vitros hstni results were not reported from the laboratory and 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).
Additional Manufacturer Narrative
The investigation determined that discordant higher than expected vitros hstni results were obtained from a single patient sample when tested using vitros hstni lot: 1510 on a vitros 5600 integrated system.The results were higher than expected when compared to a non-vitros beckman highly sensitive troponin i result below the upper reference interval (url).Neither the beckman result or url were provided.The assignable cause of the event is a sample interferent that affects the vitros hstni assays but not the non-vitros beckman method.Heterophilic antibody interference was the cause of the event as the sample was treated with heterophilic blocking tube (hbt) and non-specific antibody blocking tube (nabt), the vitros hstni results were lower from the treated samples.The hbt manufacture package insert states if the assay result from the hbt treated sample is different from the assay result from the untreated sample, the difference is due to heterophilic interference.The vitros hstni instructions for use, under other limitations states heterophilic antibodies in serum or plasma samples may cause interference in immunoassays.These antibodies may be present in blood samples from individuals regularly exposed to animals or who have been treated with animal serum products.Results that are inconsistent with clinical observations indicate the need for additional testing.There was no indication a vitros instrument related performance issue contributed to the event, however, as no diagnostic within-run precision testing was performed to assess instrument performance, an instrument related performance issue cannot be completely ruled out as contributing to the event.A performance issue with vitros hstni reagent lot 1510 did not likely contribute to the event as historical quality control results were acceptable, indicating vitros hstni reagent lot: 1510 was performing as intended.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros hstni reagent lot: 1510.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I (HSTNI) 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: 25176510
• Report Number: 3007111389-2026-00098
• Device Sequence Number: 18689709
• Product Code: MMI
• UDI-Device Identifier: 10758750033522
• UDI-Public: (01)10758750033522(17)260818(11)251223(10)1510
• 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): 05/14/2026

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 Expiration Date: 08/18/2026
• Device Catalogue Number: 6912232
• Device Lot Number: 1510
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2025
• 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