MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 4600 CHEMISTRY SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6802445
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a higher-than-expected sodium (na+) result was obtained during a within run precision test from a vitros performance verifier (pv) using vitros chemistry products na+ slides lot 4205-1178-7573 on a vitros 4600 chemistry system.The assignable cause of the event is an instrument issue related to the performance of the vitros 4600 chemistry system.The higher-than-expected result was obtained during within run precision testing and the overall results of the precision testing were not within ortho acceptable guidelines.An ortho field engineer (fe) observed a broken piece of plastic in the humidity control box of the instrument.The piece was removed and the humidity control box was replaced.Additionally, the ortho fe optimized the vitros 4600 system with all necessary adjustments.The results from post service vitros na+ diagnostic precision testing were within ortho acceptable guidelines indicating that the performance of the vitros 4600 system was returned to expectations following the service actions performed by the ortho fe.Additionally, there has been no reported recurrence from the customer of any unacceptable vitros na+ results since the service actions were performed on the vitros 4600 system.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher-than-expected sodium (na+) result was obtained during a within run precision test from a vitros performance verifier (pv) using vitros chemistry products na+ slides lot 4205-1178-7573 on a vitros 4600 chemistry system.Vitros pv i lot y2110 result of 139.1 mmol/l vs an expected result of 120.8 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+ result was obtained from a quality control fluid during within run precision testing and was not reported from the laboratory.There have been 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 (b)(4).

• Brand Name: VITROS 4600 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: 23547533
• Report Number: 1319681-2025-00052
• Device Sequence Number: 9683338
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: (01)10758750012343
• 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): 11/13/2025

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: 6802445
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2018
• 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