MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 32; IN-VITRO DIAGNOSTICS

Catalog Number	6844508
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros sodium (na+) results were obtained from a single vitros performance verifier (pv) i lot e2828 quality control fluid, using vitros na+ slide lot 4282-1162-2951 on a vitros 5600 integrated system.The cause of the event is suboptimal calibrations using vitros calibrator kit 32, lot 3254.A review of the affected calibration determined the intercept parameters were atypical when compared to the release intercept.In addition, the vitros cl assay was not affected, which would rule out an instrument performance issue with the potentiometric subsystem.Acceptable performance was obtained after performing an additional calibration event with the same calibrator lot.The cause of the suboptimal calibration was not determined.A vitros na+ slide lot 4282-1162-2951 performance issue could not be ruled out as the customer did not provide quality control data as requested.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 4282-1162-2951.The customer was requested to perform a diagnostic vitros na+ within-run precision test which is used to assess instrument function.The customer did not perform the requested precision testing; therefore, an instrument related performance issue cannot be completely ruled out as contributing to the event.
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 vitros performance verifier (pv) i lot e2828 quality control fluid, using vitros na+ slide lot 4282-1162-2951 on a vitros 5600 integrated system.Vitros pv i lot e2828 na+ results of 145.5, 146.1, 143.3 and 145.4 mmol/l vs.The expected result of 126.2 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher-than-expected vitros na+ slide lot 4282-1162-2951 results were obtained from non-patient quality control fluids.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment 612777.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 32
• 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: 23756097
• Report Number: 1319808-2025-00033
• Device Sequence Number: 15849033
• Product Code: JIX
• UDI-Device Identifier: 10758750007110
• UDI-Public: (01)10758750007110(17)260528(11)240528(10)3254
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 12/08/2025

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: 05/28/2026
• Device Catalogue Number: 6844508
• Device Lot Number: 3254
• 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: 11/11/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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