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	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros tropi es result was obtained from a single patient sample tested using vitros immunodiagnostic products troponin i es reagent pack lot 6250 tested on a vitros 5600 integrated system.The assignable cause of the event could not be determined with the information provided.No historical quality control results were provided upon request, therefore, a performance issue with vitros tropi es lot 6250 cannot be 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 product tropi es reagent lot 6250.A diagnostic vitros tropi es within-run precision testing to assess the performance of the vitros 5600 integrated system was within the acceptable guidelines, therefore, a performance issue with the vitros 5600 integrated system did not likely contribute 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 manufacture 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 quidelortho (qo) field application specialist (fas) contacted the ortho technical solutions center (tsc) on behalf of a customer to report a higher than expected vitros tropi es result obtained from a single patient sample tested using vitros immunodiagnostic products troponin i es reagent pack lot 6250 tested on a vitros 5600 integrated system.Patient sample result of 0.345 ng/ml (above the ami) vs.The repeat vitros tropi es result of <0.012 ng/ml (

• 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: 25220144
• Report Number: 3007111389-2026-00105
• Device Sequence Number: 15902992
• Product Code: MMI
• UDI-Device Identifier: 10758750002504
• UDI-Public: (01)10758750002504(17)260615(11)250812(10)6250
• 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): 05/19/2026

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: 06/15/2026
• Device Catalogue Number: 6802301
• Device Lot Number: 6250
• 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: 05/08/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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