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

Catalog Number	8379034
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	12/22/2025
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 (na+) result was obtained from a single patient sample processed using vitros chemistry products na+ slides lot 4283-1163-3395 on a vitros 5600 integrated system.Patient sample result of 141.6 mmol/l vs an expected result of 119.0 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 vitros na+ result was not reported out of 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 400298497 and reportability assessment 613155.
Additional Manufacturer Narrative
The investigation has determined that a non-reproducible, higher than expected sodium (na+) result was obtained from a single patient sample processed using vitros chemistry products na+ slides lot 4283-1163-3395 on a vitros 5600 integrated system.The investigation could not determine a definitive assignable cause of the event.Based on historical quality control results, a vitros na+ lot 4283-1163-3395 performance issue cannot be ruled out as a contributor of the event.The results of precision testing performed on the vitros 5600 system were within ortho acceptable guidelines.However, the ortho field application specialist stated that after a review of data from the vitros instrument, it was determined that the humidity level was above the acceptable range on the date of the event.No further information or any specific condition codes were provided.Therefore, a transient issue related to the humidity cannot be ruled out as a contributing factor of the event.Pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacturers recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros na+ lot 4283-1163-3395.

• 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: 24123167
• Report Number: 1319809-2026-00003
• Device Sequence Number: 15877446
• Product Code: JGS
• UDI-Device Identifier: 10758750004812
• UDI-Public: (01)10758750004812(17)261001(11)250423(10)428311633395
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/20/2026

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 Expiration Date: 10/01/2026
• Device Catalogue Number: 8379034
• Device Lot Number: 4283-1163-3395
• 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: 12/22/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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