MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS PHYT SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number	8298671
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer reported obtaining a lower than expected, non-reproducible phenytoin (phyt) result from a single patient sample using vitros phyt slide lot 2627-0194-4131 processed on a vitros xt 7600 integrated system.The definitive cause for the event could not be determined historical vitros phyt quality control results using non-vitros biorad quality controls and a vitros phyt within-run precision test indicated vitros phyt slide lot 2627-0194-4131 was performing as intended and did not likely contribute to the event.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros phyt slide lot 2627-0194-4131.A diagnostic vitros crbm within-run precision test, used to assess instrument performance was not performed, therefore, a performance issue with the vitros xt 7600 integrated system cannot be completely ruled out as contributing to the event.However, since historic vitros phyt quality control results and a vitros phyt within-run precision test were acceptable, an instrument-related performance issue did not likely contribute to the event.Finally, the affected sample was not centrifuged according to the collection device manufacture's recommendations, therefore, improper pre-analytical sample handling cannot be ruled out as a contributing factor.It is likely cellular debris, due to poor sample preparation, was 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 lower than expected, non-reproducible phenytoin (phyt) result from a single patient sample using vitros phyt slide lot 2627-0194-4131 processed on a vitros xt 7600 integrated system.Patient sample vitros phyt result of 56.7 umol/l vs.The expected vitros phyt result of 85.0 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower-than-expected vitros phyt result was not reported outside of the laboratory and 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 (b)(4).

• 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 23057000
• Report Number: 1319809-2025-00078
• Device Sequence Number: 13067885
• Product Code: DIP
• UDI-Device Identifier: 10758750004690
• UDI-Public: (01)10758750004690(17)251015(11)250517(10)262701944131
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/15/2025

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: 10/15/2025
• Device Catalogue Number: 8298671
• Device Lot Number: 2627-0194-4131
• 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: 08/18/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• 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