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	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros sodium (na+) result was obtained from a single patient sample tested on vitros 4600 chemistry system, compared to repeat testing from the same patient sample.Patient sample vitros na+ result of >250 mmol/l vs.The repeat result of 120.0 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros na+ result was not reported from the laboratory and there was no allegation of 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 a higher than expected vitros sodium (na+) result was obtained from a single patient sample tested on vitros 4600 chemistry system, compared to repeat testing from the same patient sample.The assignable cause of the event could not be determined with the information provided.The customer provided historic quality control results but did not provide any target values to assess performance.Therefore, it is not possible to determine if vitros na+ slide lot 4284-1165-3464 was performing as intended and cannot be ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros na+ slide lot 4284-1165-3464.The customer declined to perform a diagnostic within-run precision test to assess the performance of the vitros 4600 chemistry system, therefore, a performance issue with the vitros 4600 chemistry system cannot be ruled out as contributing to the event.The affected sample was not centrifuged according to the collection device manufacturers recommendations, therefore, improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

• 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: 24293996
• Report Number: 1319809-2026-00008
• Device Sequence Number: 21165423
• Product Code: JGS
• UDI-Device Identifier: 10758750004812
• UDI-Public: (01)10758750004812(17)261001(11)2504256(10)428411653464
• 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): 02/09/2026

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: 4284-1165-3464
• 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: 01/12/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• 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