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	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected sodium result obtained from a single patient sample processed using vitros chemistry products sodium (na+) slides lot 4202-1174-7452 on a vitros 4600 chemistry system.Patient result of 189.8 mmol/l vs an expected (repeat) result of 128.5 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 patient result was not reported outside of the laboratory.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 a non-reproducible, higher than expected sodium result was obtained from a single patient sample processed using vitros chemistry products sodium (na+) slides lot 4202-1174-7452 on a vitros 4600 chemistry system.The investigation could not determine a definitive assignable cause of the event.The historical quality control results revealed unacceptable within laboratory precision for both levels of qc, however, the magnitude of the imprecision noted during this timeframe is significantly less than the magnitude of the non-reproducible, higher than expected vitros na+ result observed on (b)(6) 2026, suggesting that the two issues may have two separate causes.Nonetheless, a vitros na+ slide lot 4202-1174-7452 performance issue cannot be ruled out as a contributor to the event.Additionally, an individual slide related issue also cannot be entirely ruled out as a contributing factor.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros na+ lot 4202-1174-7452.An instrument issue is an unlikely contributor to the event as vitros na+ within run precision testing around the time the higher-than-expected result was obtained indicated acceptable performance of the vitros 4600 chemistry system.However, as diagnostic precision testing to assess instrument performance was not performed, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.Pre-analytical sample processing could not be ruled out as a contributing factor as it remains unknown if the customer was following the sample collection device manufacturer recommended centrifugation protocol.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: 24627275
• Report Number: 1319809-2026-00025
• Device Sequence Number: 18317275
• Product Code: JGS
• UDI-Device Identifier: 10758750004812
• UDI-Public: (01)10758750004812(17)270201(11)250827(10)420211747452
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/18/2026

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 Catalogue Number: 8379034
• Device Lot Number: 4202-1174-7452
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• 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