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	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected sodium result was obtained from a non-vitros biorad quality control processed using vitros chemistry products na+ slides lot 4267-1147-8042 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 4267-1147-8042 performance issue is not a likely contributor of the event.However, an individual slide related issue could not be entirely ruled out.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros na+ lot 4267-1147-8042.An instrument related issue could not be entirely ruled out as a contributing factor of the event as diagnostic precision testing was not performed on the vitros 5600 integrated system.However, there was no evidence indicating that the instrument malfunctioned.An issue isolated to the biorad control is not likely a contributing factor of the event as an acceptable repeat result was obtained using an alternate aliquot from the same control vial.Additionally, multiple alternate assays produced expected results from the initial qc run that produced the higher than expected vitros na+ result.
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 non-vitros biorad quality control processed using vitros chemistry products sodium (na+) slides lot 4267-1147-8042 on a vitros 5600 integrated system.Biorad lot 92990 l2 result of >250 mmol/l vs an expected result of 122.2 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient sample, the non-reproducible, higher than expected result was from a non-patient fluid and was not reported outside of the laboratory.However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected.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 611638.

• 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 22844106
• Report Number: 1319809-2025-00073
• Device Sequence Number: 9635142
• Product Code: JGS
• UDI-Device Identifier: 10758750004812
• UDI-Public: (01)10758750004812(17)260501(11)241110(10)426711478042
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/15/2025

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: 05/01/2026
• Device Catalogue Number: 8379034
• Device Lot Number: 4267-1147-8042
• 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: 07/25/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2024
• 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