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

Catalog Number	1726926
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected vitros ammonia (amon) result was obtained from a single patient sample processed using vitros chemistry products amon slides lot: 1020-0268-5902 on a vitros 5600 integrated system.The result was higher than expected when compared to a repeat result from the same sample obtained on the sites vitros 4600 chemistry system.Patient sample vitros amon result of 111.2 umol/l versus an expected result of 24.5 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, higher than expected vitros amon result was not reported out of 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).
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected vitros ammonia (amon) result was obtained from a single patient sample processed using vitros chemistry products amon slides lot: 1020-0268-5902 on a vitros 5600 integrated system.The result was higher than expected when compared to a repeat result from the same sample obtained on the sites vitros 4600 chemistry system.A definitive assignable cause of the event could not be determined with the information provided.No quality control results to verify the performance of vitros amon lot: 1020-0268-5902 were provided and a reagent related issue could not be ruled out as a contributing factor of the event.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros amon lot: 1020-0268-5902.Microslide incubator contamination cannot be confirmed or ruled out as a contributor to the event.The customer did not process diagnostic precision testing as requested when this event was reported on 19 dec 2025.However, the customer had previously reported a higher-than-expected vitros amon result on (b)(6) 2025 as documented in (b)(4), at which time the vitros 5600 system was optimized and precision testing was acceptable both before and after the optimization.For the current event on 19 dec 2025, feedback was provided on (b)(6) 2025 stating that an ortho field engineer (fe) went to the customer site and replaced the incubation plate and belt, adjusted the dispense blade, then calibrated vitros amon lot: 1020-0268-5902 and processed quality control (qc) fluids.However, it is unable to be determined if the issue was isolated to the vitros 5600 system, as no data was provided to support the performance after the current service actions.Additionally, the patient sample had been repeated on the vitros 5600 instrument and produced an acceptable result prior to any actions being taken on the system.Lastly, the vitros 5600 system was determined to be in acceptable working order following the previous unexpected vitros amon result that occurred approximately two weeks prior to this most recent event.Pre-analytical sample processing could not be ruled out as a contributing factor to the event.As previously documented in (b)(4), the customer was not following the sample collection device manufacturers recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

• 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: 24084720
• Report Number: 1319809-2026-00002
• Device Sequence Number: 15896648
• Product Code: JID
• UDI-Device Identifier: 10758750000012
• UDI-Public: (01)10758750000012(17)270101(11)250713(10)102002685902
• 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): 01/15/2026

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: 1726926
• Device Lot Number: 1020-0268-5902
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2025
• 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