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

Catalog Number	6844461
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower-than-expected ammonia (amon) result obtained from a non-vitros mas quality control fluid processed using vitros chemistry products amon slides lot 1023-0271-0638 on a vitros xt 7600 integrated system.Mas control lot aa2709 l2 result of 121.1 umol/l vs the expected result of 160.6 umol/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 lower-than-expected vitros amon result was obtained when processing a control fluid.No results were reported out of the laboratory.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).
Additional Manufacturer Narrative
The investigation determined that a lower than expected ammonia (amon) result was obtained from a non-vitros mas quality control fluid processed using vitros chemistry products amon slides lot 1023-0271-0638 on a vitros xt 7600 integrated system.The assignable cause of the lower than expected vitros amon result is an instrument issue, likely related to microslide incubator contamination.Historical results from the mas control fluids were imprecise.Additionally, the results of a vitros amon within run precision test processed on the vitros xt 7600 system were not within ortho acceptable guidelines.An ortho field engineer (fe) performed maintenance actions on the vitros xt 7600 system which included cleaning the cm/rt ring, discard and insert blades and replacing the evaporation caps.The results of a post maintenance vitros amon within run precision test processed on the vitros xt 7600 system were within ortho acceptable guidelines indicating that the instrument performance was returned to expectations following the actions performed by the ortho fe.

• 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: 25548159
• Report Number: 1319681-2026-00045
• Device Sequence Number: 18827993
• Product Code: JJE
• UDI-Device Identifier: 10758750031610
• UDI-Public: (01)10758750031610
• 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): 06/18/2026

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: 05/27/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• 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