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

Catalog Number	1721869
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	01/09/2026
Type of Reportable Event	Malfunction
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 1020-0268-5934 on a vitros 5600 integrated system.A definitive assignable cause of the event could not be determined with the information provided.A possible cause of the event is microslide incubator contamination as the customer was using unidentified floor disinfectants in the laboratory.The type of disinfectants used and whether they contained ammonia was not provided.In v-docs of the vitros 5600 system, it states the following: cleaning solutions: do not use any solvents or cleaning solutions on any part of the vitros instrument other than distilled or deionized water.Never use ammonia cleaners on or near the vitros instrument.Caution: do not use solvents, alcohol, ammonia, glass cleaners, or cleaning agents containing abrasives to clean the incubator evaporation caps.These items will damage the caps and affect system performance.An ortho field engineer (fe) cleaned various parts of the microslide incubator sub-system of the vitros 5600 system including the evaporation caps.No direct contamination was identified by the ortho fe and no precision testing results were provided.It is unknown if any precision testing was performed.An instrument issue related to microslide incubator contamination cannot be confirmed or ruled out as a contributing factor of the event.No quality control results to verify the performance of vitros amon lot 1020-0268-5934 were provided and a reagent related issue could not be ruled out as a contributing factor of the event.However, the customer did not indicate any issues with quality control results or any other results obtained using the vitros amon slides.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros amon lot 1020-0268-5934.Pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was 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.In addition, there was no indication of how sample was handled prior to testing.Per vitros instruction for use: centrifuge specimens and remove the plasma from the cellular material within 15 minutes of collection.Keep sample on ice until analysis.
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 1020-0268-5934 on a vitros 5600 integrated system.Patient sample vitros amon result of 115.0 umol/l versus an expected result of 6.0 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) and reportability assessment (b)(4).

• 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: 24261192
• Report Number: 1319809-2026-00006
• Device Sequence Number: 15853146
• Product Code: JID
• UDI-Device Identifier: 10758750009602
• UDI-Public: (01)10758750009602(17)270101(11)250713(10)102002685934
• 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): 02/04/2026

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: 1721869
• Device Lot Number: 1020-0268-5934
• 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: 01/09/2026
• Initial Report FDA Received Date: 02/04/2026
• 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