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	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer reported obtaining a non-reproducible, lower than expected phenytoin (phyt) result from a single patient sample using vitros phyt slide lot 2627-0190-6032 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 and vitros quality controls and a vitros phyt within-run precision test indicated vitros phyt slide lot 2627-0190-6032 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 2627-0190-6032.A vitros crbm within-run precision test, used to assess instrument performance, was acceptable, indicating the vitros xt7600 integrated system was performing as intended and 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 non-reproducible, lower than expected phenytoin (phyt) result from a single patient sample using vitros phyt slide lot 2627-0190-6032 processed on a vitros xt 7600 integrated system.Patient sample vitros phyt result of 76.13 umol/l vs.The expected vitros phyt result of 143.17 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, lower than expected phyt result was reported outside of the laboratory; however, no treatment was given, changed, or withheld based on the reported result.A corrected report was issued to the physician 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: 21264581
• Report Number: 1319809-2025-00008
• Device Sequence Number: 9412592
• Product Code: DIP
• UDI-Device Identifier: 10758750004690
• UDI-Public: (01)10758750004690(17)250201(11)240909(10)262701906032
• 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): 01/27/2025

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: 02/01/2025
• Device Catalogue Number: 8298671
• Device Lot Number: 2627-0190-6032
• 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: 12/31/2024
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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