MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 350 CHEMISTRY SYSTEM; CLINICAL CHEMISTRY

Catalog Number	6802153
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2026
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 vitros ammonia (amon) result obtained from a vitros liquid performance verifier (lpv) processed using vitros chemistry products amon slides lot 1020-0267-3614 on a vitros 350 chemistry system.Vitros lpv ii lot m2779 result of 134.0 umol/l versus an expected result of 191.8 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 and no results were reported out of the laboratory.The customer stated that no patient sample results had been questioned.However, the investigation cannot conclude that patient sample results were not or would not be affected if the event were to recur undetected.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 vitros amon result was obtained from a vitros liquid performance verifier processed using vitros chemistry products amon slides lot 1020-0267-3614 on a vitros 350 chemistry system.The assignable cause of the lower than expected vitros amon result is an instrument issue likely related to microslide incubator contamination.Prior to actions performed by an ortho field engineer (fe), the customer performed actions including using fresh reagent, fresh vitros lpv fluids and recalibrating the vitros amon reagent on the instrument.These actions did not resolve the issue.An ortho fe performed actions on the vitros 350 system which included cleaning the evaporation caps, replacing the reflectance pads and recalibrating the vitros amon reagent.An ortho field application specialist confirmed that after the maintenance actions were performed on the instrument by the ortho fe, the issue was resolved.

• Brand Name: VITROS 350 CHEMISTRY 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: 24560274
• Report Number: 1319681-2026-00012
• Device Sequence Number: 9440374
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: (01)10758750002054
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/10/2026

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: 6802153
• 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: 02/14/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2019
• 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