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

Catalog Number	6802153
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros sodium (na+) result was obtained from a single level of a non-vitros thermofisher mas control (lot ocr2608) using vitros na+ slide lot 4203-1176-6973 on a vitros 350 chemistry system.The assignable cause of the event is a suboptimal calibration due to user error with calibrator kit lot selection on the vitros analyzer.The calibrator kit that the customer was using (cal kit 2, lot 0214) was not the calibrator kit that the vitros 350 chemistry system was configured for (cal kit 2, lot 0293) at the time of the calibration events.The ortho technical solutions center (tsc) assisted the customer with changing their vitros cal kit lot configuration to the correct cal kit 2 lot number.The customer recalibrated the vitros na+ assay.Post calibration qc results were slightly outside the package insert range but showed substantially less bias than the elevated vitros na+ results observed on (b)(6) 2026.In follow up, the customer reported acceptable na+ performance but provided no data upon request.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros sodium (na+) result was obtained from a single level of a non-vitros thermofisher mas control (lot ocr2608) using vitros na+ slide lot 4203-1176-6973 on a vitros 350 chemistry system.Mas ocr2608 level 1 result of 140.5 mmol/l vs.The expected result of 120.5 mmol/l the higher than expected results were obtained from a non-patient quality control sample, however, the investigation cannot conclude that patient sample results were not or would not be affected if the event were to recur undetected.There were no reported 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 613239.

• Brand Name: VITROS 350 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: 24271063
• Report Number: 1319681-2026-00003
• Device Sequence Number: 18647179
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: (01)10758750002054
• 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): 02/04/2026

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: 01/08/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2020
• 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