MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS XT 3400 CHEMISTRY SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6844458
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report non-reproducible, higher than expected vitros sodium (na+) results were obtained from vitros performance verifier (pv) i e2828 using three different vitros na+ slide lots tested on a vitros xt3400 integrated system.Vitros na+ slide lot 4209-1181-9128 vitros pv i e2828 result of 140.8 mmol/l vs.The baseline mean of 126.0 mmol/l vitros na+ slide lot 4214-1186-0987 vitros pv i e2828 result of 158.1, 158.0, 141.9, and 149.5 mmol/l vs.The baseline mean of 126.0 mmol/l vitros na+ slide lot 4220-1191-2809 vitros pv i e2828 result of 147.3 mmol/l vs.The baseline mean of 126.0 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 non-patient quality control fluid.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that non-reproducible, higher than expected vitros sodium (na+) results were obtained from vitros performance verifier (pv) i e2828 using three different vitros na+ slide lots tested on a vitros xt3400 integrated system.The most likely assignable cause of the event is an instrument related performance issue.Multiple diagnostic vitros na+ within-run precision tests were outside of acceptable guidelines, indicating the vitros xt3400 integrated system was not performing as intended.Acceptable na+ performance was obtained after a quidelortho field engineer (fe) replaced the electrometer and erf pump.The quidelortho fe examined vitros na+ slide lot 4214-1186-0987 and saw scratches on the slides.It is unlikely a damaged slide related issue contributed to the event as three different vitros na+ slide lots were affected.In addition, the customer has not reported the same issue occurring on an alternate vitros analyzer on site.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros na+ slides lots 4209-1181-9128, 4214-1186-0987 and 4220-1191-2809.

• Brand Name: VITROS XT 3400 CHEMISTRY 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: 25027363
• Report Number: 1319681-2026-00028
• Device Sequence Number: 9175575
• Product Code: JJE
• UDI-Device Identifier: 10758750031986
• UDI-Public: (01)10758750031986
• 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): 04/29/2026

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: 6844458
• 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: 04/03/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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