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	01/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros sodium (na+) results were obtained from a single non-vitros biorad level 1 quality control fluid, lot 93030, using vitros na+ slides on a vitros 5600 integrated system.The most likely cause of the suboptimal calibrations could not be determined with the information provided.The event was isolated to two calibration events performed on (b)(6) 2026 (calibration curves 18331 and 18337).The calibrations were suboptimal when compared to the calibration responses and parameters generated when calibrator kit 2, lot 0224 was released.The vitros calibration kit in use for both calibration events was vitros cal kit 224.No information was provided concerning the type of pipette used for reconstitution or pre-analytical sample handling or storage of the calibrator kit 2, lot 0224 fluids.Therefore, reconstitution using an inaccurate pipette or improper pre-analytical sample handling or storage of the calibrator kit 2, lot 0224 fluids cannot be ruled out as contributing to the event.Acceptable vitros na+ performance was observed after a calibration event was performed using an alternate lot of calibrator fluids, calibrator kit 2, lot 0235.The investigation found no indication the vitros 5600 integrated system or vitros na+ slide lot 4202-1174-7380 contributed to the event.Historical qc was acceptable prior to the first 18 jan 2026 calibration event.Additionally, 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 4202-1174-7380.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros sodium (na+) results were obtained from a single non-vitros biorad level 1 quality control fluid, lot 93030, using vitros na+ slides on a vitros 5600 integrated system.Biorad level 1 na+ results of 137.1 and 140.1mmol/l vs.The expected result of 123.1 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The affected samples were non-patient quality control samples.There was no allegation of patient harm as a result of this event.This report is number two of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.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: 24331936
• Report Number: 1319808-2026-00007
• Device Sequence Number: 15900434
• Product Code: JIX
• UDI-Device Identifier: 10758750009503
• UDI-Public: (01)10758750009503(17)261223(11)241223(10)0224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: 1662659
• Device Lot Number: 0224
• 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: 01/18/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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