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

Catalog Number	6802413
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros sodium (na+) results were obtained from a single level of non-vitros biorad quality control (qc) fluid (lot 89760) using vitros na+ slide lot 4275-1156-1471 on a vitros 5600 integrated system.Biorad level 2 (lot 89760) vitros na+ results of 135.5 and 139.7 mmol/l versus the expected result of 127.5 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 when processing a non-patient control fluid.No results were reported out of the laboratory.The customer claimed that patient results were not impacted by this issue.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 (b)(4).
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros sodium (na+) results were obtained from a single level of non-vitros biorad quality control (qc) fluid (lot 89760) using vitros na+ slide lot 4275-1156-1471 on a vitros 5600 integrated system.The assignable cause of the event is an issue related to the vitros 5600 integrated system.The historical quality control (qc) results surrounding the time of the event demonstrated imprecision of the vitros na+ assay on both levels of qc fluid and inaccuracy of level 1 qc fluid.An ortho field application specialist (fas) arrived onsite on 01 october 2025 and cleaned the potentiometric (pm) slots and pm anti-evaporation caps on the vitros pm microslide assembly.Following the optimization of the pm subsystem, the ortho fas recalibrated the vitros na+ slide lot 4275-1156-1471 using an alternate vitros calibrator (vitros calibrator kit 32, lot 3275) and post-calibration qc was determined to be acceptable.Vitros na+ assay performance was monitored for two weeks after the ortho fas's service actions and assay performance was determined to be acceptable.This further demonstrated that the higher than expected vitros na+ results were resolved by service actions performed by the ortho fas, specifically, cleaning of the pm subsystem on the vitros 5600 integrated system.The results of a vitros na+ diagnostic precision test performed on 30 october 2025 were within expectations, verifying that this maintenance action performed by the ortho fas had resolved the issue.

• Brand Name: VITROS 5600 INTEGRATED 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: 23606863
• Report Number: 1319681-2025-00057
• Device Sequence Number: 21311814
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: (01)10758750002740
• 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): 11/20/2025

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: 10/01/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• 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