MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 5600 INTEGRATED SYSTEM; CLINICAL CHEMISTRY

Catalog Number	6802413
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	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected sodium result was obtained from a single patient sample processed using vitros chemistry products sodium (na+) slides lot 4264-1144-6695 on a vitros 5600 integrated system.Patient sample result of >250 mmol/l vs an expected result of 126.8 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, higher than expected patient sample result was not reported outside of the laboratory.There has been no reported allegation 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 611147.
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected sodium result was obtained from a single patient sample processed using vitros chemistry products sodium (na+) slides lot 4264-1144-6695 on a vitros 5600 integrated system.The assignable cause of the event is an instrument related issue.An ortho field engineer completed service actions on the vitros 5600 system which included dispense blade adjustments, metering adjustments, inspecting and cleaning the incubator and verifying the electrolyte reference fluid alignment.A post service diagnostic precision test performed on the instrument yielded results that were within ortho acceptable guidelines.Additionally, a review of e-connectivity data did not identify any further non-reproducible, higher than expected vitros na+ patient sample results for the customer since service actions were performed on the vitros 5600 system.

• Brand Name: VITROS 5600 INTEGRATED 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 22320281
• Report Number: 1319681-2025-00030
• Device Sequence Number: 18398113
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: (01)10758750002740(11)210319
• 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): 06/24/2025

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: 6802413
• 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: 06/03/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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