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 Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An ortho field application specialist (fas) contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) on behalf of a customer to report a discordant, higher than expected troponin i result was obtained from a single patient sample processed using vitros immunodiagnostic products hs troponin i (hstni) reagent lot 1380 on a vitros 5600 integrated system.Patient sample vitros hstni result of 1.723 ng/l (above the ami cutoff) vs the expected result of < 1.50 ng/l (below ami cutoff) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, higher than expected vitros hstni result 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 400306348 and reportability assessment 613817.
Additional Manufacturer Narrative
The investigation determined that a discordant, higher than expected troponin i result was obtained from a single patient sample processed using vitros immunodiagnostic products hs troponin i (hstni) reagent lot 1380 on a vitros 5600 integrated system.A definitive assignable cause of the event could not be determined.Historical quality control (qc) results for l1 of non-vitros biorad fluid indicated acceptable performance leading up to the day of the event.However, l2 qc fluid was not provided when requested.In addition, it was unknown if the customer processed a qc fluid at or below the vitros hstni url.Therefore, the performance of the vitros hstni lot 1170 at, or below the overall url concentration of 11 ng/l or around the l1 qc fluid concentration cannot be determined and a reagent issue could not be entirely ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros hstni lot 1380.Pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the sample collection device manufacturer recommended centrifugation protocol was properly followed.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Although a vitros diagnostic precision test was not performed on the vitros 5600 integrated system, an analyzer-related issue is not a likely contributor to the event as there was no indication of an instrument malfunction reported by the customer and the affected sample was repeated twice with acceptable, reproducible results on the day of the event without any action being performed on the analyzer.

• 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: 24687084
• Report Number: 3007111389-2026-00051
• Device Sequence Number: 9706014
• Product Code: MMI
• UDI-Device Identifier: 10758750033522
• UDI-Public: (01)10758750033522(17)260427(11)250901(10)1380
• 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): 03/25/2026

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: 04/27/2026
• Device Catalogue Number: 6912232
• Device Lot Number: 1380
• 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: 02/27/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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