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	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that higher than expected sodium results were obtained from a non-vitros biorad quality control using vitros chemistry products na+ slides lot 4201-1173-6016 on a vitros xt 7600 integrated system.The assignable cause of the event is an instrument issue related to the performance of the vitros xt 7600 integrated system.Historical quality control results for vitros na+ lot 4201-1173-6016 were imprecise and not acceptable.An ortho field application specialist (fas) went to the customer site and observed that the electrolyte reference fluid (erf) tip sleeve was missing.The fas installed the tip sleeve, inspected the erf tubing, and replaced the erf reservoir and tip.Acceptable vitros na+ diagnostic precision testing was obtained following these actions, however additional higher than expected biorad qc results were obtained approximately a week later, at which time an ortho field engineer (fe) was sent to the customer site to evaluate the vitros xt 7600 system.The ortho field engineer completed actions on the instrument which included maintenance of the erf sub-system, including cleaning the cam, sensors, and tip locator.Additionally, the fe adjusted the reference dispensing position, verified and optimized the pm ring stop and cleaned the evaporation caps.The ortho fe then performed leak tests on the dispensing pump and subsequently conducted performance tests which yielded optimal operational values.Following service actions performed by the ortho fe, vitros na+ results for the customer returned to expectations.
Event or Problem Description
An ortho field application specialist (fas), on behalf of a customer, contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected sodium results obtained from a non-vitros biorad quality control using vitros chemistry products sodium (na+) slides lot 4201-1173-6016 on a vitros xt 7600 integrated system.Biorad lot 89760 l2 results of 156.3, 151.3, 154.8, 154.9, 158.0, 154.2, 155.4 and 163.0 mmol/l vs an expected result of 127.8 mmol/l 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-than-expected vitros na+ results were obtained from a quality control fluid and were not reported from the laboratory.The ortho tsc inquired if any patient sample results have been affected or questioned, however, the customer did not provide any information.There have been no 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 (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: 25171468
• Report Number: 1319681-2026-00030
• Device Sequence Number: 10566765
• Product Code: JJE
• UDI-Device Identifier: 10758750031610
• UDI-Public: (01)10758750031610
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 05/14/2026

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: 04/22/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2019
• 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