MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS NA+ SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number	8379034
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
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 sodium results were obtained from a vitros performance verifier (pv) quality control fluid using vitros chemistry products sodium (na+) slides lot: 4282-1162-3122 on a vitros 5600 integrated system.Vitros pv i e2828 results of 139.7, 138.8 and 140.2 mmol/l vs.The expected result of 126.2 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 from a quality control fluid and no results were reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).
Additional Manufacturer Narrative
The investigation has determined that higher than expected sodium results were obtained from a vitros performance verifier (pv) quality control fluid using vitros chemistry products sodium (na+) slides lot: 4282-1162-3122 on a vitros 5600 integrated system.The assignable cause of the event is improper protocol performed by the customer when preparing and using the vitros products.The customer was not warming the vitros na+ slide cartridges for the required amount of time after removing them from storage and before loading and using them on the vitros 5600 system.Additionally, the customer was warming the vitros calibrator kit 2 and vitros performance verifier vials longer than recommended and was not reconstituting the vials as recommended in the product instructions for use.After using fresh vitros products prepared by following the product(s) instructions for use, vitros na+ results returned to expectations for the customer.

• Brand Name: VITROS CHEMISTRY PRODUCTS NA+ SLIDES
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 23535304
• Report Number: 1319809-2025-00088
• Device Sequence Number: 13303752
• Product Code: JGS
• UDI-Device Identifier: 10758750004812
• UDI-Public: (01)10758750004812(17)261001(11)250413(10)428211623122
• 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): 11/10/2025

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 Expiration Date: 10/01/2026
• Device Catalogue Number: 8379034
• Device Lot Number: 4282-1162-3122
• 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: 10/13/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2025
• 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