MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2; IN-VITRO DIAGNOSTICS

Catalog Number	1662659
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected sodium results were obtained from a vitros performance verifier (pv) processed using vitros chemistry products sodium (na+) slides lot 4282-1162-3115 on a vitros 350 chemistry system.The assignable cause of the higher-than-expected vitros na+ results is a suboptimal calibration.The parameters from the calibration used to obtain the higher-than-expected quality control results were atypical when compared to the database values.The cause of the suboptimal calibration is unknown.The ortho tsc reviewed the customers protocol for preparing and handling the vitros na+ reagent, vitros cal kit 2 and vitros pv fluids and concluded that the customer was following the recommended protocols listed in the product(s) instructions for use (ifu).An ortho field application specialist has been scheduled to visit the site to assist the customer with troubleshooting actions including inspecting the electrolyte reference fluid pump, processing a vitros na+ diagnostic precision test and recalibrating the vitros na+ reagent on the instrument using vitros cal kit 32 in place of kit 2.These actions are expected to resolve the issue.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros na+ reagent lot 4282-1162-3115 or any of the vitros products in use at the customer site.
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) processed using vitros chemistry products sodium (na+) slides lot 4282-1162-3115 on a vitros 350 chemistry system.Vitros pv i lot e2828 results of 141.0 and 136.9 mmol/l vs the expected result of 126.2 mmol/l biased results of the magnitude and direction observed may led to inappropriate physician action if they were to occur undetected on patient samples.The higher-than-expected results were from a non-patient control fluid and were not reported from the laboratory.There was 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).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
• 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.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 23547040
• Report Number: 1319808-2025-00032
• Device Sequence Number: 13123900
• Product Code: JIX
• UDI-Device Identifier: 10758750009503
• UDI-Public: (01)10758750009503(17)260701(11)240701(10)0214
• 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): 11/12/2025

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: 07/01/2026
• Device Catalogue Number: 1662659
• Device Lot Number: 0214
• 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: 10/15/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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