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

Catalog Number	1726926
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros ammonia (amon) result was obtained from a patient sample processed using vitros chemistry products amon slides lot 1020-0267-3614 on a vitros 5600 integrated system.Patient result of 141.3 umol/l versus the expected result of 23.1 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros amon result was not reported from the laboratory.There have been no reported allegations 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 higher than expected vitros ammonia (amon) result was obtained from a patient sample processed using vitros chemistry products amon slides lot 1020-0267-3614 on a vitros 5600 integrated system.The assignable cause of the higher than expected result could not be determined with the information provided.No historical vitros amon qc lot 1020-0267-3614 results were provided for assessment, however the customer gave no indication of any issues with the qc fluid.Additionally, an ortho field application specialist stated qc results were within expectation on the day of the event.Based on this limited information, it is not possible to rule out an issue with vitros amon lot 1020-0267-3614.However, continual tracking and trending does not indicate a systemic quality issue with vitros amon lot 1020-0267-3614.The customer was not following the sample collection device manufacturers recommendation for sample centrifugation.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.An ortho field application specialist (fas) stated that multiple results were abnormally high across the three vitros amon lot 1020-0267-3614 reagent cartridges that were on board the vitros 5600 system at the time of the event, although results from only a single patient were provided.The fas stated that subsequent testing showed a decrease in results, however it is unknown if results decreased within these same vitros amon lot 1020-0267-3614 reagent cartridges or if new cartridges were loaded.An unknown issue isolated to the reagent cartridge in use at the time of the event can not be confirmed or ruled out.The complaint handling unit (chu) requested that the customer process a vitros amon within run precision test on the vitros 5600 systemin in order to rule out microslide incubator contamination.The fas processed an unspecified quality control fluid and stated that repeatability was good.The ortho fas additionally processed 31 patient samples and two levels of control fluids across two different cartridges of vitros amon lot 1020-0267-3614 and did not observe any additional higher than expected results.No results or fluid concentrations were provided for assessment.However, based on the fas assessment of acceptable performance, an issue with the vitros 5600 system is not a likely contributor to the event.

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON 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: 23804158
• Report Number: 1319809-2025-00097
• Device Sequence Number: 9360039
• Product Code: JID
• UDI-Device Identifier: 10758750000012
• UDI-Public: (01)10758750000012(17)261101(11)250503(10)102002673614
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/15/2025

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 Catalogue Number: 1726926
• Device Lot Number: 1020-0267-3614
• 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: 11/19/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2025
• 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