MAUDE Adverse Event Report: Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products PHYT Slides; In-Vitro Diagnostics

Catalog Number	8298671
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros phyt results obtained from a vitros therapeutic drug monitoring performance verifier (tdm pv) fluid using vitros chemistry products phyt slide lot 2631-0202-6006 on a vitros xt7600 integrated system.Vitros tdm pv iii lot u3323 vitros phyt results of 22.68, 17.05, 20.88, 16.82, and 18.77 ug/ml versus the expected result of 29.2 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros phyt results were obtained from a non-patient quality control fluid.There were no allegations of patient harm as a result of this event.This report is number four of five 3500a forms being submitted for this event as five devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros phyt results were obtained from a vitros therapeutic drug monitoring performance verifier (tdm pv) fluid using vitros chemistry products phyt slide lot 2631-0202-6006 on a vitros xt7600 integrated system.The most likely assignable cause was the vitros phyt slide lot 2631-0202-6006 in use at the site.Acceptable vitros phyt performance was obtained when an alternate vitros phyt slide lot was put into use without performing any actions to optimize the vitros xt7600 integrated system.The customer was requested to perform a vitros phyt within-run precision test in order to assess the performance of vitros phyt slide lot 2631-0202-6006, however, the customer declined to perform the precision testing.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt slide lot 2631-0202-6006.No diagnostic vitros crbm within-run precision test was performed that would assess the performance of the immunorate subsystem of the vitros xt7600 integrated system.However, since acceptable vitros phyt performance was obtained when an alternate vitros phyt slide lot was put into use without performing any actions to optimize the vitros xt7600 integrated system, a performance issue with the vitros xt7600 integrated system did not likely contribute to the event.

• Brand Name: VITROS Chemistry Products PHYT Slides
• 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, Inc.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; +1(585)453-4165
• MDR Report Key: 50181763
• Report Number: 1319809-2026-00109
• Device Sequence Number: 18203566
• Product Code: DIP
• UDI-Device Identifier: 10758750004690
• UDI-Public: (01)10758750004690(17)261015(11)260520(10)263102026006
• 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): 08/07/2026

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: 8298671
• Device Lot Number: 2631-0202-6006
• 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: 07/14/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2026
• 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