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

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	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros ammonia (amon) results were obtained from a non-vitros mas alcohol/ammonia control processed using vitros amon slide lot 1020-0268-5827 on a vitros xt 7600 integrated system.The assignable cause of the lower-than-expected vitros amon results is an instrument issue related to ammonia contamination of the microslide incubator.The cause of the ammonia contamination was not determined.The historical quality control (qc) results surrounding the time of the event demonstrated imprecision of the vitros amon assay on both levels of qc fluid.Additionally, a vitros amon precision test was outside ortho acceptable guidelines.An ortho field engineer went to the customer site and replaced the microslide metering pump, the z pump motor, and the cm/rt evaporation caps.Following these service actions, a repeat vitros amon precision test was within ortho acceptable guidelines, verifying that the service actions performed by the ortho field engineer resolved the issue.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros ammonia (amon) results were obtained from a non-vitros mas alcohol/ammonia control processed using vitros amon slide lot 1020-0268-5827 on a vitros xt 7600 integrated system.Mas level 2 lot aa2604 vitros amon results of 113.85, 110.8, and 113.5 umol/l versus the expected result of 142.75 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 results were obtained when processing a control fluid.No results were reported out of the laboratory.The customer stated that patient results were not impacted by this issue.There has been no reported 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 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: 23597465
• Report Number: 1319681-2025-00054
• Device Sequence Number: 18470826
• 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): 11/19/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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