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

Catalog Number	6802445
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower than expected vitros sodium (na+) result was obtained from processing a single patient sample using vitros na+ slide lot 4201-1173-6380 on a vitros 4600 chemistry system.The result was lower than expected when compared to a vitros result obtained from testing the same patient sample on an alternate vitros analyzer on site.The assignable cause of the event was an instrument related performance issue.An ortho field engineer (fe) went on site and determined the issue appeared to be related to electrolyte reference fluid (erf) pump drop dispensing.The erf drop was not falling centered on the slide, which caused the condition codes and affected patient results.The ortho fe performed adjustments to the erf metering.Acceptable performance was obtained after the service actions were completed, along with performing an additional calibration of vitros na+ slide lot 4201-1173-6380.No pre-service diagnostic vitros na+ within-run precision testing was performed prior to the service actions being performed, however, historic pre-service quality control results indicated vitros na+ slide lot 4201-1173-6380 was not performing as intended with regards to accuracy and precision.Acceptable performance was obtained after the service actions were completed.The customer was not following proper cartridge handling or calibrator fluid handling when compared to the vitros na+ and calibrator kit 2 instructions for use.Therefore, improper cartridge and fluid handling cannot be ruled out as contributing to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower-than-expected vitros sodium (na+) result was obtained from processing a single patient sample using vitros na+ slide lot 4201-1173-6380 on a vitros 4600 chemistry system.The result was lower than expected when compared to a vitros result obtained from testing the same patient sample on an alternate vitros analyzer on site.Patient sample 1 vitros result of 126.0 mmol/l vs.The expected result of 169.0 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower-than-expected result was obtained from the single patient sample but was not released from the laboratory.The customer confirmed that 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).

• 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: 24433647
• Report Number: 1319681-2026-00009
• Device Sequence Number: 13336686
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: (01)10758750012343
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 02/24/2026

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: 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: 01/30/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2020
• 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