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

Catalog Number	6802301
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros troponin i es (tropi es) result was obtained from a single patient sample tested using vitros tropi es reagent lot 6240 tested on a vitros xt7600 integrated system.The assignable cause of the event could not be determined with the information provided.A historic quality control review indicates vitros tropi es reagent lot 6240 was not performing as intended within the timeframe.However, the bias is negative, while the customer reported a higher than expected result.In addition, the customer does not process a quality control fluid with a troponin i concentration at or below the url.Therefore, the performance of the vitros tropi es reagent lot 6240 at, or below the url concentration of 0.034 ng/ml 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 tropi es lot 6240.No diagnostic within-run precision testing to assess the performance of the vitros xt7600 integrated system was performed, therefore, a performance issue with the vitros xt7600 integrated system could not be ruled out as a contributor to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was unknown if the customer was following the sample collection device manufactures recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was potentially present in the affected sample, although this could not be confirmed.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros troponin i es (tropi es) result was obtained from a single patient sample tested using vitros tropi es reagent lot 6240 tested on a vitros xt7600 integrated system.Patient sample vitros tropies result of 0.091 ng/ml (above the url) vs.The vitros hstni result below the 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 tropi es result was not reported from the laboratory.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) and reportability assessment 613971.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES 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: 24844236
• Report Number: 3007111389-2026-00073
• Device Sequence Number: 14865644
• Product Code: MMI
• UDI-Device Identifier: 10758750002504
• UDI-Public: (01)10758750002504(17)260604(11)250801(10)6240
• 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): 04/10/2026

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: 06/04/2026
• Device Catalogue Number: 6802301
• Device Lot Number: 6240
• 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: 03/13/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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