MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS DGXN SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number	8343386
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros digoxin (dgxn) result was obtained when performing a patient correlation study using vitros dgxn lot 1937-0275-8241 on a vitros 5600 integrated system.The assignable cause of the event could not be determined.No historical quality control results were available for review leading up to the event aside from post-calibration results obtained six days prior to the event, which were within expectation.There is not sufficient historical information to rule out an issue with vitros dgxn lot 937-0275-8241.However, continual tracking and trending does not indicate a systemic issue with vitros dgxn lot 937-0275-8241.Precision testing was acceptable, indicating an issue with the vitros 5600 system did not likely contribute to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros digoxin (dgxn) result was obtained when performing a patient correlation study using vitros dgxn lot 1937-0275-8241 on a vitros 5600 integrated system.Vitros dgxn patient 5 result of 1.50 nmol/l versus the expected result of 0.59 nmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The vitros dgxn result was obtained during a patient correlation and was not reported out of the laboratory.There was no 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 DGXN 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: 23820647
• Report Number: 1319809-2025-00100
• Device Sequence Number: 9386847
• Product Code: LFM
• UDI-Device Identifier: 10758750004782
• UDI-Public: (01)10758750004782(17)260215(11)250921(10)193702758241
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/16/2025

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: 02/15/2026
• Device Catalogue Number: 8343386
• Device Lot Number: 1937-0275-8241
• 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: 11/21/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2025
• 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