MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS XT 7600 INTEGRATED SYSTEM; CLINICAL CHEMISTRY

Catalog Number	6844461
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that reproducible, higher-than-expected troponin es results were obtained from four different patient samples when using vitros immunodiagnostic products troponin i es (tropi es) reagent pack, lot: 6390 on a vitros xt 7600 integrated system.The results were considered discordant when compared to repeat results obtained from the same patient samples on a second vitros xt 7600 integrated system.Additionally, higher than expected vitros tropi es lot: 6390 results were obtained during a precision test using specialty diluent fluid (known troponin free sample).The assignable cause of the higher-than-expected results was likely an instrument issue related to incubator contamination.The results of two vitros tropi es within run precision tests performed on the vitros instrument by the customer were not within ortho acceptable guidelines.It was established that the customer was not performing routine cleaning and maintenance on the vitros xt 7600 integrated system in accordance with ortho guidelines.An ortho senior field engineer (sfe) visited the customer site and performed service and maintenance actions, including a deep cleaning of the microwell incubator, replaced all wet signal reagent components.Following these actions, the ortho sfe conducted a within-run vitros tropi es precision test on the instrument, which yielded acceptable results, indicating that the service actions restored the vitros analyzer to expected performance.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report reproducible, higher-than-expected troponin es results obtained from four different patient samples when using vitros immunodiagnostic products troponin i es (tropi es) reagent pack, lot: 6390 on a vitros xt 7600 integrated system.The results were considered discordant when compared to repeat results obtained from the same patient samples on a second vitros xt 7600 integrated system.Additionally, higher than expected vitros tropi es lot: 6390 results were obtained during a precision test using specialty diluent fluid (known troponin free sample).Vitros xt 7600 integrated system: s/n: (b)(6) (j1) patient 1, vitros tropi es result of 0.069 ng/ml versus the expected result of <0.012 ng/ml patient 2, vitros tropi es results of 0.087, 0.072, and 0.075 ng/ml versus the expected result of <0.012 ng/ml patient 3, vitros tropi es results of 0.078 and 0.057 ng/ml versus the expected result of <0.012 ng/ml patient 4, vitros tropi es result of 0.073 ng/ml versus the expected result of <0.012 ng/ml vitros tropi es precision results of 0.061, 0.059 and 0.067 ng/ml versus the expected result of <0.012 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The reproducible higher-than-expected vitros tropi es results were not reported from the laboratory.There was no allegation of harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).

• Brand Name: VITROS XT 7600 INTEGRATED SYSTEM
• Common Device Name: CLINICAL CHEMISTRY
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24799596
• Report Number: 1319681-2026-00021
• Device Sequence Number: 21216903
• Product Code: JJE
• UDI-Device Identifier: 10758750031610
• UDI-Public: (01)10758750031610
• 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): 04/07/2026

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 Catalogue Number: 6844461
• 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: 03/16/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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