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

Catalog Number	6844461
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher and lower than expected phenytoin (phyt) results were obtained from non-vitros biorad quality controls processed using vitros chemistry products phyt slides lot 2627-0193-5577 on a vitros xt 7600 integrated system.The assignable cause of the lower and higher than expected vitros phyt results is an instrument related issue.Historical quality control results were found to be imprecise.Additionally, the customer had stated the same lot of vitros phyt reagent was performing within expectations along with the same biorad controls on the site's alternate vitros instrument.An ortho field engineer (fe) replaced the tubing of the immunorate subsystem of the vitros xt 7600 system and performed adjustments to the subsystem.Following service actions, vitros phyt control results have returned to expectations.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher and lower than expected phenytoin (phyt) results were obtained from non-vitros biorad quality controls processed using vitros chemistry products phyt slides lot 2627-0193-5577 on a vitros xt 7600 integrated system.Biorad lot 40450 level 2 result of 8.35 ug/ml vs an expected result of 12.59 ug/ml biorad lot 40450 level 3 results of 15.94, 15.32, 17.45, 26.87, 16.34, 16.25 and 31.58 ug/ml vs an expected result of 22.33 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 higher and lower than expected results were obtained from non-patient control fluids and were not reported from the laboratory.The customer did not indicate that any patient sample results had been affected.There have been no reported allegations 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 612208.

• Brand Name: VITROS XT 7600 INTEGRATED SYSTEM
• Common Device Name: CHEMISTRY ANALYZER
• 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: 23336370
• Report Number: 1319681-2025-00051
• Device Sequence Number: 21195208
• Product Code: JJE
• UDI-Device Identifier: 10758750031610
• UDI-Public: (01)10758750031610
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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 Catalogue Number: 6844461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2019
• 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